SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 1064/532 LASER SYSTEM

K973603 · Schwartz Electro-Optics, Inc. · GEX · Dec 19, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K973603
• Device Name: SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 1064/532 LASER SYSTEM
• Applicant: Schwartz Electro-Optics, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Schwartz Electro-Optics, Inc. CrystaLase 1064/532 will be indicated for removal of tattoos of various types and colors, epidermal and pigmented lesions. These indications have been cleared for marketing by the Food and Drug Administration for the cited predicated lasers. Schwartz Electro-Optics, Inc. seeks no new indications for the CrystaLase 1064/532.

Device Story

CrystaLase 1064/532 is a laser system delivering energy at 1064 nm (Nd:YAG) and 532 nm (frequency-doubled Nd:YAG). Device used by clinicians for tattoo removal and treatment of epidermal/pigmented lesions. Operates via laser energy delivery to target tissue. System design and mechanical/electronic characteristics are similar to predicate Nd:YAG laser systems.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological similarity to predicate devices.

Technological Characteristics

Laser system; Nd:YAG medium; dual wavelength output at 1064 nm and 532 nm (frequency-doubled). Mechanical and electronic architecture similar to predicate Nd:YAG lasers.

Indications for Use

Indicated for removal of tattoos of various types and colors, and epidermal and pigmented lesions in patients requiring dermatological laser treatment.

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.

Predicate Devices

• Continuum Biomedical Medlite
• DermaLase

Submission Summary (Full Text)

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## k973603

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS SCHWARTZ ELECTRO-OPTICS, Inc. CRYSTALASE 1064/532

From a technology perspective, theory of operation of all the aforementioned devices are While the laser mediums are identical, all the systems are similar both all the same. and electronically. Schwartz Electro-Optics, Inc. believes that the mechanically technological characteristics of the CrystaLase 1064/532 are similar to the predicate lasers. The Continuum Biomedical Medlite and the DermaLase have the ability to deliver laser energy at wavelengths of 1064 nm (Nd:YAG) and frequency doubled Nd:YAG at 532 nm (Green).

In regards to safety or effectiveness of the Schwartz Electro-Optics, Inc. CrystaLase 1064/532, Schwartz Electro-Optics, Inc. believes that the slight differences in the performance characteristics of these devices raises no concerns.

- This information was prepared for the sole purpose of compliance with the Advisory: Safe Medical Devices Act of 1990. It does not imply that the procedures described herein can be performed with the equipment described without substantial risk of personal injury or death to patients due to operator error or in procedures requiring a high degree of skill.
**Prescription Use**
(Per 21 CFR 801.109)

IX.

(Division Sign-Off)
Division of General Restorative Device
510(k) Number

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 19 1997

Mr. Timothy J. Shea Director Schwartz Electro-Optics. Incorporated 3404 N. Orange Blossom Trail Orlando, Florida 32804

Re: K973603 Trade Name: CrystaLase 1064/532 Laser System Regulatory Class: II Product Code: GEX Dated: September 2, 1997 Received: September 22, 1997

Dear Mr. Shea:

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 requirements , as set forth in the Quality 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

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devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, 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.

fciellaf

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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## SCHWARTZ ELECTRO-OPTICS, INC.

September 30, 1997

DEC 1 9 1997

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, MD 20850

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## Indications for Use Schwartz Electro-Optics, Inc. CrystaLase 1064/532

The Schwartz Electro-Optics, Inc. CrystaLase 1064/532 will be indicated for removal of tattoos of various types and colors, epidermal and pigmented lesions. These indications have been cleared for marketing by the Food and Drug Administration for the cited predicated lasers. Schwartz Electro-Optics, Inc. seeks no new indications for the CrystaLase 1064/532.