(86 days)
The Alexis Alexandrite Laser System and accessories are indicated for: Cosmetic and Plastic Surgery Photocoagulation of dermatological vascular lesions Treatment of cutaneous vascular and pigmented lesions
Not Found
The provided document is a 510(k) clearance letter from the FDA for a medical device (Alexis™ Alexandrite Laser System and Accessories). It approves the device for market based on substantial equivalence to a predicate device, but it does not contain any information regarding acceptance criteria, study data, or performance metrics of the device.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval and indications for use, not on the technical performance specifications or the studies supporting those specifications.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, with three abstract shapes representing human figures.
0 1898 JUL
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Marilyn M. Chou. Ph.D. Executive Vice President Convergent Laser Technologies A Subsidiary of Xintec Corporation 900 Alice Street Oakland, California 94607
- Re: K981350
Trade Name: Alexis™Alexandrite Laser System and Accessories Regulatory Class: II Product Code: GEX Dated: April 10, 1998 Received: April 14, 1998
Dear Dr. Chou:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 requirements , as set forth in the Quality System Regulation (OS) 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. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions 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
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Page 2 - Marilyn M. Chou, Ph.D.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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) 594-4648. Additionally, for questions on the promotion and advertising of your devices, 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,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ATTACHMENT B: INDICATIONS FOR USE.
K#981350 510(k) Number :
Alexis™ Alexandrite Laser System and Accessories Device Name: | |
Indications For Use:
JUN-28-1998
The Alexis Alexandrite Laser System and accessories are indicated for:
Cosmetic and Plastic Surgery
Photocoagulation of dermatological vascular lesions
Treatment of cutaneous vascular and pigmented lesions
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(21 CFR 801.109) X
OR
Over-The-Counter Use __
tive Devices
98135
§ 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.