|Subject:||Electronic Product Radiation Control|
|Issuer:||Center for Devices and Radiological Health|
|Issued:||July 12, 2010||Closed:||
Department of Health and Human Services
Public Health Service
Food and Drug Administration
10903 New Hampshire Ave.
White Oak #66 - 4621
Silver Spring, MD 20903-0002
JUL 12 2010
via UNITED PARCEL SERVICE
Mr. Chung Tien aka Citi Cheng
340 Dewpoint Lane
Alpharetta, GA 30027
Dear Mr. Cheng:
This letter notifies you that the United States (U.S.) Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) hereby disapproves the quality control and testing program for all laser products produced by Amstech Incorporated, Alpharetta, Georgia, USA. This action is taken under the authority of the U.S. Federal Food, Drug, and Cosmetic Act (the Act), Chapter V, Subchapter C - Electronic Product Radiation Control, Section 534 [h) [U.S.C. 360kk(h)].
Based on the findings listed below, the CDRH finds that Amstech Incorporated has failed to conduct a testing program which ensures compliance with the applicable performance standard, 21 CFR 1010.2(c).
This disapproval means that your firm is prohibited by Sections 534(h) and 538(a) of the Act from:
1. certifying the electronic products manufactured under the disapproved testing program (§ 538 (a) (5) (B)),
2. introducing, delivering for introduction, or importing into the U.S. commerce any product which does not comply with the applicable standard (§ 538(a) (1)), and
3. introducing or importing into U.S. commerce any product which does not have a certification as required by section 534 (h) (§ 538 (a) (5) (A)).
This letter is written to advise you of items of noncompliance with the Aimshot HeatSeeker encountered during the June 23, 2009 inspection of Amstech Inc. (also known as AimSHOT) conducted by Leo J. Lagrotte of the Food and Drug Administration (FDA), Southeast Regional Electro-Optics Specialist and Investigator for the Florida District Office.
The inspection report submitted by Mr. Lagrotte has been reviewed. Mr. Lagrotte reported that the following observations were made:
1. 21 Code of Federal Regulations (CFR) 1010.2(c): The electronic product failed to be certified based upon a testing program in accordance with good manufacturing practices. Specifically, your firm failed to document the final power test results for the Aimshot HeatSeeker.
2. 21 CFR 1040.10 (h) (1) (iv): Informational requirement was missing a warning; "Caution - use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure." Specifically, your user manuals provided with the Aimshot HeatSeeker, failed to include the warning.
3. 21 CFR 1040.11(b): The Class IIIb product fails to comply with the class limits in § 1040.11(b) applicable to surveying, leveling, and alignment (SLA) laser products. Specifically, the Aimshot HeatSeeker is a Class IIIb infrared laser used for targeting to draw the attention of persons with night-vision equipment to a specific area. It is limited to Class I in the infrared.
Based on information and data provided in your reports and information from your website at
. we find the Aimshot HeatSeeker is classified as a specific purpose laser product under 1040.11(b). The Center for Devices and Radiological Health considers lasers used for pointing out objects to be "surveying, leveling, and alignment laser products" because they are within the definition in 21 CFR 1040.10(b) (39):
"(39) Surveying, leveling, or alignment laser product means a laser product manufactured, designed, intended or promoted for one or more of the following uses:
(i) Determining and delineating the form, extent, or position of a point, body, or area by taking angular measurement.
(ii) Positioning or adjusting parts in proper relation to one another.
(iii) Defining a plane, level, elevation, or straight line."
The Federal Regulations, in 21 CFR 1040.11(b), limit surveying, leveling, and alignment laser products to Class IIIa. i.e., 5 milliwatts (mW) in the visible spectrum:
"(b) Surveying, leveling, and alignment laser products. Each surveying, leveling, or alignment laser product shall comply with all of the applicable requirements of § 1040.10 for a Class I, IIa, II or IIIa laser product and shall not permit human access to laser radiation in excess of the accessible emission limits of Class IIIa."
According to 21 CFR 1040.10(c) (40), visible radiation has wavelengths greater than 400 nanometers (nm) in length but less than or equal to 710 nm. Radiation in the infrared region is invisible because the wavelength is longer than 710 nm. Since the accessible emission limits of Class IIa, II and IIIa laser radiation do not apply to wavelengths longer than 710 nm, infrared lasers cannot be classified as IIa, II or IlIa. Therefore, surveying, leveling and alignment laser products that emit infrared (invisible) laser radiation are limited to Class I.
This letter is written to advise you of the following items of noncompliance with 10 mW Class IIIb red laser sight Model LS6800 sold with the KT-6832 Red Laser Rifle Kit, 12 mW Class IIIb Green Laser Sight Model LS8200 and 20 mW Class IIIb LS8300 Green Laser Sight Model LS8300, determined after review of your product reports and your company website at
1. 21 CFR 1040.11(b): These Class IIIb products fail to comply with the class limits in § 1040.11(b) applicable to surveying, leveling, and alignment laser products. Specifically, the LS6800, LS8200 and LS8300 are Class IIIb visible lasers used as gunsights for pointing purposes. They are limited to Class IIIa in the visible.
Section 538(a) of the Act, 21 U.S.C. § 360oo(a), prohibits any manufacturer from certifying or introducing into commerce electronic products which do not comply with an applicable standard. This section also prohibits any manufacturer from failing or refusing to establish and maintain required records or to submit required reports. Failure to respond to this letter may be considered to be a violation of section 538(a) (4) of the Act, 21 U.S.C. § 360oo(a) (4). FDA is prepared to invoke regulatory actions if you fail to comply with these requirements. These actions may include an injunction and/or imposition of civil penalties as provided for in section 539 of the Act, 21 U.S.C. § 360pp. Persons who violate section 538 of the Act are subject to civil penalties of up to $1,100 per violation and up to a maximum penalty of $355,000 without further notification by the FDA. In cases where a foreign manufacturer fails to respond, penalties may be imposed upon importers.
You are required, under 21 C.F.R. 1003.11(b), to immediately provide a written response to FDA with the number of referenced products which have been produced and the number of such products that have left the place of manufacture. In addition, if the product distribution was confined to specific geographical areas of the United States, please specify those areas. We request that you provide such a response no later than 15 days after receipt of this letter with one of the options listed below:
1. Refutation - Under 21 C.F.R. 1003.11(a) (3), you may submit your views and evidence to establish that the alleged failures to comply do not exist.
2. Exemption Request - Under 21 C.F.R. 1003.30(a), you may request an exemption from user and dealer/distributor notification requirements in Under 21 C.F.R. 1003.10(b). You must respond within 15 days from receipt of this letter to apply for such an exemption. If exempted from such notification, you are not required to correct the violative products (under 21 C.F.R. 1004.1(a)). Your request must include the grounds upon which such exemption is requested (see 21 C.F.R. 1003.30 and 1003.31) and the information required under 21 C.F.R. 1003.20.
3. Purchaser Notification and Corrective Action - If you neither refute the noncompliance nor request an exemption, then you must: (a) notify purchasers and dealers / distributors of the violative products as specified in 21 C.F.R. 1003.10(b), and (b) submit a written corrective action plan (CAP) for approval showing how you will fulfill your obligation under 21 C.F.R. 1004.1 to repair, replace, or refund the cost of the violative products.
a. Notification Letter - Requirements for preparation of notification letters are prescribed in 21 C.F.R. 1003.21 and 1003.22. A copy of the notification letter(s) sent to purchasers and dealers must also be sent to the FDA. It is recommended that you submit a draft of this letter to us for review.
b. Corrective Action Plan - Instructions for preparation of a CAP may be found in 21 C.F.R. 1004.2, 1004.3, or 1004.4. Such a plan must expeditiously correct the noncompliances and must be approved as set out in 21 C.F.R. 1004.6.
If you request additional time to prepare your refutation, notification, CAP, or evidence to support a requested exemption, you must provide the reasons for any delays and a reasonable target date for the full submission of your response. Be aware that if an acceptable CAP cannot be prepared promptly, you may be required to proceed with interim notification to affected persons as required by 21 CFR 1003.11(c) and 1003.21. Therefore, you are encouraged to immediately begin your preparation of accurate user location lists.
The following failure to comply with the regulations regarding reports and record keeping were observed:
1. 21 CFR 1002.10: The manufacturer of a product requiring a product report shall submit a product report to CDRH. Specifically, the CDRH has not received a product report for the LS68XX Series 5 mW Class IlIa red laser sight advertised for sale on the
2. CFR 1002.13: The manufacturer of a product requiring an annual report shall submit an annual report summarizing the contents of records required to maintained by § 1002.30(a).
a. Annual reports from 2005 to 2009 identify the AimShot HeatSeeker as a Class IIIa laser product. However, your product report, accession number
, classifies the infrared laser as Class IIIb.
b. The 2009 annual report is missing the production status, number produced, and test status for the following models reported in previous year annual reports; LS8200, LS6100, LS6200, LS6300, LS6500, LS6502, LS6600, LS6602, and HS3000.
c. Annual reports from 2005 to 2009 do not provide the production status, number produced, and test status of:
i. The LS68XX Series, accession number
, advertised for sale on the
website as Class IIIb red laser sight Model LS6800.
Series Azeotek, accession number
, advertised for sale on the
website as Green Laser Pointer.
iii. The LS85XX, LS87XX, LS86XX, and LS826XX Series AimShot Green Laser Sights, accession numbers (b)(4) , (b)(4) , (b)(4) and (b)(4) respectively.
In summary, to resolve this matter, you must:
1. provide a list of all laser models manufactured or sold,
2. submit all the information required under 21 CFR 1002.10 such that the CDRH can determine that Amstech Inc. is in compliance with the Act, that all future production complies with the performance standard, and that the testing program is in accord with good manufacturing practices, and
3. submit a CAP for the following products that have been sold:
a. Aimshot HeatSeeker
b. 10 mW Class IIIb red laser sight Model LS6800 sold with the KT-6832 Red Laser Rifle Kit
c. 12 mW Class IIIb Green Laser Sight Model LS8200
d. 20 mW Class IIIb LS8300 Green Laser Sight Model LS8300
The CDRH will advise you whether your submittal is satisfactory. You must have an adequate quality control program to certify product currently in stock before a CAP will be approved to correct noncompliances of all sold products.
Your response should be sent to:
Chief, Electronic Products Branch
Division of Mammography Quality and Radiation Programs
Office of Communication, Education, and Radiation Programs
Center for Devices and Radiological Health
10903 New Hampshire Ave., W066-4621
Silver Spring, Maryland 20993-0002
If you have further questions on these requirements, please contact CAPT Dan Hewett of the Electronic Products Branch at (301) 796-5864.
Lynne L. Rice
Office of Communication, Education,
and Radiation Programs
Center for Devices and