- Laserworld Usa Inc
- Issuing Office:
- Center for Devices and Radiological Health
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
Silver Spring, MD 20993
September 26, 2014
Mr. Francis Oliveira
41 Skyline Drive, Suite 1017
LAKE MARY FL 32747
Re: FDA Reference Numbers: COR14000218, COR14000219
Dear Mr. Oliveira:
This letter is written to advise you of your high-power laser light show projectors, models CS-1000RGB (COR14000218) and CS-2000RGB (COR14000219), and our discovery of noncompliance with the Federal Food, Drug, and Cosmetic Act (Act), Subchapter C, Electronic Product Radiation Control, Section 538(a) [U.S.C. § 360oo(a)]discovered during an FDA evaluation of these laser products which were purchased by the U.S. government.
The following is a list of the failures to comply with 21 CFR 1010.4, 1040.10, and 1040.11(c) that we found:
1. 21 CFR 1040.10 (f)(2)(i) Failure to provide safety interlocks at each part of the protective housing which is displaced during maintenance. For example, your firm included the following statement in your report with the Accession Number 1220374-012 which was filed for laser light show projectors, including models CS-1000 RGB and CS-2000 RGB:
“Housing does not incorporate interlocks. […] Housing removal is not permitted and requires ‘special tools’. Housing access is only permitted at the factory for assembly or service”.
However, the user’s manual shipped by your firm with the above mentioned projectors includes the following instructions for your customers which are in conflict with your statement above: “2. Preliminary warning notices […] Please use this device only according to these operating instructions. (bold fonts used in your manual at this point)[…] “ and “5. Service notes […] Open the device at regular intervals and dust regularly around fans and laser. Otherwise, the risk of overheating is imminent and will void the warranty”. Your user’s manual failed to provide clear warning regarding the potential exposure to Class IV laser emissions after the opening of the enclosure.
Because your firm advises users to perform a maintenance activity that includes removal of access panels of protective housing, in accordance with 21 CFR 1040.10 (f)(2)(i), safety interlocks must have been provided at each part of the protective housing which is displaced during maintenance. Our evaluation confirmed that your firm did not provide the required safety interlocks. Please note that the opening of the enclosure described in your user manual sent to a U.S. customer meets the requirements for maintenance according to 21 CFR 1040.10(b)(24).
Although your product report asserts that “special tools” are required to open the protective enclosure, FDA was able to complete this task by removing typical Phillips screws with a regular Phillips screwdriver.
2. 21 CFR 1040.10(f)(3) For models CS-1000RGB and CS-2000RGB, failure to provide a remote interlock connector that, when its terminals are not electrically joined, prevents human access to all laser radiation exceeding the accessible emission limits of Class I from the laser product. In the two projectors evaluated by FDA, after the terminal connections were opened and the laser emissions were terminated, switching off the power switch resulted in clearly visible laser emissions outside the protective housing above the accessible emission limits for Laser Class I.
3. 21 CFR 1040.10(f)(4) For models CS-1000RGB and CS-2000RGB, failure to provide a key-actuated master control which prevents operation of the laser when the key is removed. In the two projectors, evaluated by FDA, after the key was removed and the lasers were terminated, switching off the power switch resulted in clearly visible laser emissions.
4. 21 CFR 1040.10(f)(10) For models CS-1000RGB and CS-2000RGB, failure to provide a manual reset which would enable a resumption of laser radiation after a loss of electrical power mains for more than 5 seconds for laser products classified as Class IV. For example, after the above mentioned projectors were disconnected from mains power supply for 10 seconds, the projector was energized again. After several seconds, the laser emissions were initiated without any additional manual actions.
5. 21 CFR 1040.10(f)(5) For models CS-1000RGB and CS-2000RGB, failure to provide a laser radiation emission indicator which meets requirements of this paragraph. There is neither marking on the enclosure nor there is any reference in the user manual related to a laser radiation emission indicator.
6. 21 CFR 1040.10(h)(i) For models CS-1000RGB and CS-2000RGB, the content of the user manual included in the product report with the Accession Number 1220374-012 and supplied to CDRH is at many laser safety related points directly in conflict with the user manual supplied to a customer in the U.S.A.
For example, the user manual in the product report warns:
“CAUTION LASER DIODE; NEVER open the device”
The actual user manual advises the customer to open the enclosure and perform a maintenance activity. During the latter procedure, the user could sustain a very serious eye injury as a result of exposure to Class 4 laser beams.
Further, the statement of Par. 6.1 f) in IEC60825-1 Ed. 2 indicates:
“Caution - use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure.”
The above statement is included in the report submitted to CDRH, but it is missing in the user manual sent to a U.S. customer.
The user manuals shipped with projectors CS-1000RGB and CS-2000RGB failed to include explanations concerning the location and operation of the laser radiation emission indicators.
7. 21 CFR 1010.4(d)(3) Failure to list the variance number and the effective date of the variance assigned to Laserworld USA, FDA Docket No. 2012-V-0766, on the certification labels placed on the laser projectors CS-1000RGB and CS-2000RGB. Rather, these certification labels refer to variance approval “86V-0194 effective 12-31-2010” used for Lasertainment Productions International, Inc., Blaince, Minnesota.
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 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 non-compliances 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.
When you have completed any production changes necessary to assure compliance of future units and you have submitted the required reports and report supplements, you may resume introduction of these products into commerce.
Please respond within 15 days and submit your response to:
U.S. Food and Drug Administration
Center for Devices and Radiological Health
Attn: Magnetic Resonance and Electronic Products Branch
Document Control Center -- WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
You are also requested to send a copy of your response to:
Director, Compliance Branch
Florida District Office, Food and Drug Administration
555 Windereley Place Suite 200,
Maitland, FL 32751
Should you have any questions or comments pertaining to this letter, please contact Dale Smith at the above letterhead address, by telephone at (301) 796-5868 or by e-mail at firstname.lastname@example.org
or Woody Strzelecki at the above letterhead address, by telephone at (301) 796-6939 or by email at email@example.com. In any written follow-up response, please clearly reference FDA reference numbers: COR14000218 and COR14000219.
Mary S. Pastel, Sc.D.
Deputy Director for Radiological Health
Office of In Vitro Diagnostics
and Radiological Health
Center for Devices and Radiological Health