ALEXIS ALEXANDRITE LASER SYSTEM AND ACCESSORIES

K981350 · Xintec Corporation · GEX · Jul 9, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K981350
• Device Name: ALEXIS ALEXANDRITE LASER SYSTEM AND ACCESSORIES
• Applicant: Xintec Corporation
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Alexis Alexandrite Laser System utilizes alexandrite laser technology to deliver energy for photocoagulation of dermatological vascular lesions and treatment of cutaneous vascular and pigmented lesions. Operated by physicians in clinical settings; device targets specific skin lesions via laser emission. Output consists of controlled laser energy; clinical decision-making relies on physician assessment of lesion type and patient skin condition. Benefits include non-invasive or minimally invasive treatment of vascular and pigmented skin conditions.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on 510(k) notification review.

Technological Characteristics

Alexandrite laser system; energy source is laser radiation; intended for dermatological applications. Specific materials and software architecture not detailed in provided documentation.

Indications for Use

Indicated for patients requiring treatment of dermatological vascular lesions and cutaneous vascular and pigmented lesions within the scope of cosmetic and plastic surgery.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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