(86 days)
The indications for use for the above product family is:
- Iridectomy/Iridotomy.
- Posterior Capsulotomy.
- Posterior Membranectomies.
Not Found
I'm sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Laserex Q-S/W Nd:YAG Lasers). It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific details requested in your prompt regarding a study that proves the device meets acceptance criteria.
The letter explicitly states that the device is "substantially equivalent" to predicate devices, which is the basis for its clearance, not necessarily a demonstration of meeting specific performance acceptance criteria through a clinical or technical study as you've outlined.
Therefore, I cannot provide the requested information based on the given text.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 7 1999
Mr. Keith R. Degenhardt Laserex Systems USA c/o Ellex Laser Systems 258 Halifax Street Adelaide, South Australia 5000
K992824 Re: Trade Name: Laserex Q-S/W Nd:YAG Lasers Regulatory Class: II Product Code: GEX Dated: August 9, 1999 Received: August 23, 1999
Dear Mr. Degenhardt:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Ouality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 -- Mr. Keith R. Degenhardt
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Hipt Rivdis
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| Page 1 of 1 | |||
|---|---|---|---|
| 510(k) Number (if known): | K992824 | ||
| Device Name: | Ophthalmic Laser Models: Laserex LQ2106, Laserex LQP3106, Laserex 3000LX, Alcon 3000LE, Laserex LQP4106 and Coherent "AURA" (Laserex LQ5106) | ||
| Indications for Use: |
ad Radiological Hoolth
The indications for use for the above product family is:
-
- Iridectomy/Iridotomy.
.
- Iridectomy/Iridotomy.
ﺎ
。
- Posterior Capsulotomy.
-
-
-
- Posterior Membranectom1es.
-
-
,
ﻪ ﺑﻪ
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurence of CDRH, Office of Device Evaulation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K992824 |
|---|---|
| --------------- | --------- |
| Prescription Use (Per 21 CFR 801.109) | X |
|---|---|
| Over-the-Counter Use |
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.