IA# 95-04, -----2/10/99, Attachment - 10/28/04
SUBJ: IMPORT ALERT #95-04, "DETENTION WITHOUT PHYSICAL EXAMINATION OF LASER
POINTERS, LASER GUNSIGHTS, LASER LEVELS, LASER LIGHT SHOWS, LASER POINTER KEY
CHAINS, & SIMILAR PRODUCTS THAT FAIL TO COMPLY WITH APPLICABLE PERFORMANCE
STANDARDS AND REPORTING REQUIREMENTS."
This import alert represents the Agency's current guidance to FDA field personnel
regarding the manufacturer(s) and/or product(s) at issue. It does not create or
confer any rights for, or on any person, and does not operate to bind the FDA or
the public.
TYPE OF ALERT: Detention Without Physical Examination
PRODUCTS: Laser Pointers, Laser Gunsights, Laser Pens, Laser Light Show
Projectors, Laser Special Effects, Laser Levels, Toy Guns with
Lasers, Laser Pointer Key Chains, and similar products.
PRODUCT CODE: 95L-22
PROBLEM: Fails to Meet Performance Standard
Not Certified
Failure to File a Product Report
OASIS
CHARGE CODES: NON STD; NO TAG; NO REGISTR
PAF: PER, LBL
PAC: 86007
COUNTRY: See Attachment
MANUFACTURER/
SHIPPER: See Attachment
CHARGE: For products from the manufacturers/shippers listed on the
attachment to this alert charge:
"The article is subject to refusal of admission pursuant to
Section 536(a) of the Federal Food, Drug, and Cosmetic Act
(FFDCA) in that it appears to be an electronic product which
fails to comply with an applicable standard as prescribed
under subchapter C of the Federal Food, Drug, and Cosmetic Act
(FFDCA) or to which is not affixed a certification in the form
of a label or tag in conformity with Section 534(h)."[NON
STANDARD, Section 536(a)] and/or [NOT CERTIFIED, Section
534(h)] (OASIS CHARGE CODES = NON STD, NO TAG).
RECOMMENDING
OFFICE: SAN-DO, HFR-PA152 and
Center for Devices and Radiological Health (CDRH)
REASON
FOR ALERT: On December 18, 1997, FDA issued a press release on the misuse
of laser pointers. The FDA warned parents and school
officials about the possibility of eye damage to children from
hand-held laser pointers. These products are generally safe
when used as intended by teachers and lecturers to highlight
areas on a chart or screen. However, recent price reductions
have led to wider marketing, and the FDA is concerned about
the promotion and use of these products as children's toys.
The San Francisco District (SAN-DO) and the United States
Customs Service recently completed surveillance of imported
laser pointers, laser levels, and laser light shows for
compliance. SAN-DO identified seven Taiwan manufacturers and
one Chinese manufacturer whose laser products were subject to
refusal under sections 536 of the FFDCA, and appeared to be in
violation of section 534, 21 CFR 1002.10, 1010.2, 1010.3
and/or 1040.10(g) and (h).
Each shipment was either identified in OASIS as being in
compliance, or included with its entry documents an FD-2877
with Affirmation "B" checked (indicating that the product is
in compliance and labeled appropriately). The information in
the document was determined to be false, in that the products
had no certifications that they complied with the appropriate
performance standard for laser products, and/or had no
permanently attached warning logotype labels. In addition,
for some shipments, CDRH had not received product reports from
these manufacturers.
Seven out of the nine Taiwan manufacturers covered during the
surveillance shipped products that were violative. Only one
entry from China was entered, and that was also violative.
GUIDANCE: Districts may detain without physical examination (DWPE) all
shipments of laser pointers, laser gunsights, laser levels,
laser pointer key chains, laser light show projectors, and
similar products from the manufacturers/shippers listed on the
attachment to this alert.
Districts may continue to detain shipments of laser pointers,
laser gunsights, laser levels, laser pointer key chains, laser
light show projectors, and similar products which upon
examination do not appear to comply with the appropriate
standard as follows:
(1) they do not have a permanently attached warning logotype
label;
(2) they exceed 5 milliwatts;
(3) there is no certification or identification information
either on the product or in the instructions for use;
(4) there are no instructions for safe use;
(5) the product class or output information on the warning
logotype label is different from that in the instructions for
use; or
(6) a product report has not been submitted.
This alert does not cover detention of shipments of laser
pointers, laser levels, laser gunsights, laser light show
projectors, laser pointer key chains, and similar products
where:
(1) there is not an emission indicator;
(2) there is not a separate beam attenuator; or
(3) the certification and identification information is in the
instructions for use rather than on the product itself.
Products that are detained may subsequently be refused
admission unless the importer corrects deficiencies, files a
report, or is able to show that the product is properly
certified and meets the Performance Standards (21 CFR 1010.2,
1010.3, 1040.10 and 1040.11). It may be necessary to field
test some products to ensure the importer has made the
appropriate corrections. CDRH should be contacted for
additional guidance and for information regarding submission
of required reports (Jerry Dennis, 301-594-4654).
FOI: No purging required.
KEYWORDS: Laser pointer, laser pen, laser show projector, toy laser gun,
laser, laser key chain, laser gunsight
PREPARED BY: Fredda Shere-Valenti, DIOP, HFC-170
(301) 443-6553
DATE LOADED
INTO FIARS: February 10, 1999
ATTACHMENT TO IMPORT ALERT #95-04 10/28/04
MANUFACTURER PRODUCT
CANADA
M-Laser Laser Products for Non-Medical Use
815 Boul. Saint-Joseph Quest Laser-Based Level Tool
Drummondville 95L -- 22
Quebec, Canada 2/4/04
FEI# 3003996105
CHINA
Casix, Inc., Laser Products for non-medical use/
P. O. Box 1103 Laser Pointer/95L--22
Fuzhou 4/20/00
Fujian 350014
China
FEI #1000637503
Casix Laser Division Products for non-medical use/
No. 51, 195 Lane Laser Pointer/95L--22
Tian Ling Road 4/20/00
Shanghai 200233
China
FEI #3002987646
Dong Guan Comet Electronics Laser Pointer
(HK) Ltd.
Zader Industry St.
Wen Tang, Fucheng
Dong Guan City, China
FEI#: 3002572787
Dong Laixi Electronics Laser Pointer
(Shen Zhen) Co., Ltd. Laser Pen
4th Floor, Bldg.3, Ling-Ming Area Laser Key Chain
Zhong-Shen - Yuan Rd.
Nan-Shan
Sen shen, China
FEI#: 3002557008
N.C.W. Enterprise Co., Ltd. Laser Products for Non-Medical
Flat 502 505, 5/F Use, Laser Light Show Projection
Metro Centre II Equipment
21 Lam Hing Street 95L -- 22
Kowloon Bay 10/8/03
Hong Kong, China
FEI #3000225685
Ningbo Seahorse Electronic Co Laser Pointers
Dajiahe Town, Ninghi 95l22
Ningeo, China 5/28/99
Post Code 315611
FEI# 3002706480
RGB-Laser Show Co., Ltd. Laser product for non-medical
No. 668 Chuangxin Road use/Laser Projectors/95L--22
High-Tech Zone 10/28/04
Changchun 130012
China
FEI #3004820356
Rumzing Laser Products for Non-Medical
4th, Da Hong Men Westroad Use, Laser Light Show Projection
Fengtal District Equipment
Beijing 10075 95L -- 22
China 09/24/03
FEI #3004128288
Suzhou Import and Export Laser Pointer
Co., Ltd. (Group) China
MMMC, 6Fl. International Economic
Trade Mansion
6X1 Huan Road
Suzhou, China
FEI#: 3001313702
Zhejiang Materials Chemical & Light Laser pointers
Industry Co., Ltd. 95L- - 22
A-10f F1 Goudu Developing Mansion No. 182 06/4/03
Hangzhou, China
FEI #3003937902
HONG KONG
Comet Electronics (HK) Ltd. Laser Pointer
603 Sunbeam Ctr.
27 Sheng Yip St.
Kwum Tong
Kowloon, Hong Kong
FEI#: 3002572777
Daily Rank Electronics Company, Ltd. Laser Pointer Key Chains
Flat S, 9F 95L22
Valiant Industrial Center 4/5/01
2-12 Au-Pui-Wan Street
Fo-Tan, N.T.
Hong Kong
FEI# 3001878765
^
^
DS-Max HK, Ltd. Laser Pointer
8 Lam Lok St., Unit 2 Fl/10
Kowloon, Hong Kong
FEI#: 1000271793
^ ^ Products for Laser Light Show
^ ^ Laser Projectors/95L--22
^ ^ /Model LV-700, Model LF-300
^ ^ Laser Fantasy, Model MV-30
Miracle Vision, and
Model Laser Vision
(Country of Origin: China and/or
Taiwan)
9/24/02
Solomon Systech Limited Laser Pointers
Units 1-9, 37F, Tower 1 Millenium Laser Pens
388 Kwun Tong Road, Kwun Tong 9/28/01
Kowloon, Hong Kong
FEI #3003329112
FLORIDA
^ ^ Laser products for non-medical use,
^ ^ Laser light show projection equipment
^ ^ 95L- - 22
^ ^ 06/17/03
TAIWAN
Arach Technology & Application Corp. Laser Pointer
14, Lane 158, Li-sheng Rd,
Hsinchu, Taiwan, R.O.C.
FEI#: 3002174949
Bao Lih Der Co. Laser product for non-medical
22 Jen Ai St. use/Laser Projectors/95L--22
Lu Chou City 10/28/04
Taipei, Taiwan
FEI #3004565898
Dan's Goods International Co., Ltd. Laser Pointers
Taipei World Trade Center, Rm., 3F20
No 5, Sec. 5
Hsin-Yi Rd., Taipei
Taiwan
FEI#: 3001426554
Denva Technology Ltd. Laser Pointer
3F, No. 324, Sec. 2 Laser Watch
Ta-Tung Road
His-Chih, Taipei Hsien
Taiwan, R.O.C.
FEI#: 3001444246
Eastone Industries Company Laser Pointer
200, San Chun St. Laser Pen
Shu-Lin Chen Laser Keychain
Taipei, Taiwan, R.O.C.
FEI#: 3001390363
Etrade Enterprise Co., Ltd. Laser Pointer
No. 23, Wu-Chun Rd. Laser Pen
Wu Ku Industrial Park Laser Keychain
Taipei, Taiwan, R.O.C.
FEI#: 3002557033
First Creation Industry Co., Inc. Laser Pointer
3F, No. 45, Ho Ping Rd. Laser Pen
Panchiao Laser Keychain
Taipei, Taiwan, R.O.C.
FEI#: 3002557066
Gainunion Co., Ltd. Laser Pointer
No. 18, Lane 483, Chung Kang Rd. Laser Pen
Hsin Chung City Laser Keychain
Taipei, Taiwan, R.O.C.
FEI#: 3002557084
Giant Gun Electrical & Optical Co., Ltd. Laser Pointer
13, Lane 81., Sec.2 Laser Pen
Tan Fu Road Laser Keychain
Taichung Hsien, R.O.C.
FEI#: 3001085158
Go Forward Co., Ltd. Laser Pointer
1F, No. 346, Shui Yuan Rd. Laser Pen
Feng Yuan City Laser Keychain
Taichung, Taiwan, R.O.C.
FEI#: 3000985245
Ideal International Co., Ltd. Laser Pointer
3F, No. 188 Chung Chen 1 Rd.
Ying-Ko Chen
Taipei, Taiwan, R.O.C.
FEI#: 3002557097
Jaguar Pen (Taiwan) Co. Ltd Laser Pointers
1F No. 24 Lane 315 , Jen Al Street Laser Pens
Sanchung City, Taipei County 9/28/01
Taiwan
FEI #3003442067
Jen Jong Co., Ltd. Laser Pointer
No. 32 Lane 421, Wen Hua Rd.
1 Sec. Pan Chiao
Taipei, Taiwan
FEI#: 3002557101
Manufacturer:
Lei Fond or Lei Feng Ind. Co. Ltd* Laser Pointers/95L[][]22
41 No. 11 Alley B, Land 151, Sec 2 6/21/99
Chung Taipei, Taiwan, ROC
FEI #3001667840
Shipper:
Likelisa Enterprises Co., Ltd
3F No 40-1 Sec 3 Po An Street
Shu Lin Chen, Taipei Hsien
Taiwan, ROC
FEI #3001808093
*Please note that products maybe entered under either company name. The address
remains the same.
Litelong Enterprises, Inc. Laser Pointer
No. 35 Juin-An St.
Shu-Lin Chen
Taipei Hsien
Taiwan, R.O.C.
FEI#: 3001946967
^ ^ Products for Laser Light Show
^ ^ Laser Projectors/95L--22
^ ^ /Model LV-700, Model LF-300
^ ^ Laser Fantasy, Model MV-30
Miracle Vision, and
Model Laser Vision
(Country of Origin:
China and/or Taiwan)
9/24/02
Moonlight Illuminator Co., Ltd. Laser Products for non-medical
No. 10, Alley 41, Lane 116 use/laser light show projection
Chun Ying Street equipment/95L--22
Shluin Chen 10/19/04
Taipei Hsein, Taiwan
FEI: 3004784210
Opti-Magician Technology Co., Inc.* Laser Pointer
No. 20, Lane 88 Laser Keychains
Kwan-Fu Rd. Sec. 2 95L22
Sang Chung City
Taipei, Taiwan R.O.C.
FEI#: 3002095489
Opti-Magician Technology Co. Ltd.* All Laser Products
No. 32 Kwang-Hwa Road Product Code: 95L22
Sang Chung Update of second firm addressTaipei
Hsien, Taiwan - 9/22/99
FEI#3002277681
*Second manufacturing site
Optical Instrument Mfg. Co., Ltd. Laser Pointer
No.1, Lane 253, Chung-Cheng Rd. Laser Keychains
Shu-Line, Taipei Hsien
Taiwan R.O.C.
FEI#: 3001835101
Panmedic Co., Ltd Laser Pens
1F, No. 210, Chien-Keng Road 95L22
Taipei, Taiwan 7/7/00
FEI #3002988549
Shawo Hwa Industrial Co., Ltd. Laser Pointer
No. 87, Lane 98, Lih Der Street Laser Keychains
Chung Ho City
Taipei, Taiwan
FEI#: 3001556180
Shin Chen Technologies Co., Ltd. Laser Pointer
5F-5 No. 14 Alley 609 Laser Keychains
Chung-Hsing Rd., Sec.5
San Chung City, Taipei
Taiwan, R.O.C.
FEI#: 3002561333
Simpatico Industries Ltd. Laser Pointer
6F, No. 815, Sec. 5 Laser Keychains
Chung Hsaio E. Road Laser Levels
Taipei 115, Taiwan, R.O.C. Laser Pens
FEI#: 1000402507
Suncat Co., Ltd. Laser pointers
No. 13-2, Lane 23, Min Ben St. 95L[][]22
Hsinchuang City, Taiwan 4/28/00
FEI# 3002977837
Tah Chung Steel Corp. Laser Pointer
No. 6-26 S.Kao-Shjan Ting
Yang Mei
Tac Yuan, Taiwan R.O.C.
FEI#: 3001427238
Tietolaite Ky International Corp. Laser Pointer Pen
No. 34 Jio Zu 1 St Road 95L22
Kaohsiung, Taiwan 11/5/99
FEI# 1000133013
Visualtek Technology Co., Ltd. Laser Pointer
11F-4, No. 421, Song Shan Rd.
Taipei, Taiwan R.O.C.
FEI#: 3002570398
Visualtek Technology Co., Ltd Laser Pointers
6-26 S. Kao-Shan-Ting Yang Mei 95L[][]22
Tao Yuan, Taiwan 6/18/99
FEI #3002401318
Vivitek Co., Ltd. Laser Pointer
14, 266, 2nd Wen-Huva Road, Sec. 1
Linkon, Taipei Hsien
Taiwan, R.O.C.
FEI#: 3002561346
Yoow Diing Enterprise Co., Ltd. Laser Pointer
No. 49, Lane 100, Sec.2
Da-Feng Rd. Tan-Tzu Village
Taichung Hsien, Taiwan
FEI#: 3002561347