SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE

K974039 · Schwartz Electro-Optics, Inc. · GEX · Jan 12, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K974039
• Device Name: SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE
• Applicant: Schwartz Electro-Optics, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

As previously cleared, the Schwartz Electro-Optics, Inc. CLR 2940 is indicated for use in small and large joint Arthroscopy, including laparoscopic procedures, general and all surgical procedures for cutting (incision), vaporizing, ablating and coagulating soft tissue and cartilage. All soft tissues encountered in all surgical procedures are included in this indication such as, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The CLR 2940 may also be used for skin resurfacing and the treatment of wrinkles.

Device Story

CLR 2940 Erbium CrystaLase is an Erbium-based laser system; functions by delivering laser energy to target soft tissue and cartilage for incision, vaporization, ablation, and coagulation. Used in clinical settings by surgeons across multiple specialties; device operates via mechanical and electronic systems similar to predicate Erbium lasers. Output is controlled laser energy; enables precise tissue interaction for surgical procedures and dermatological applications like skin resurfacing. Benefits include versatile soft tissue management and aesthetic skin treatment.

Clinical Evidence

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

Technological Characteristics

Erbium-based laser system; utilizes same laser medium as predicate devices. System architecture is mechanical and electronic. No specific materials or software algorithms described.

Indications for Use

Indicated for patients requiring surgical cutting, vaporization, ablation, or coagulation of soft tissue and cartilage across various surgical specialties including general, plastic, podiatric, urologic, gynecologic, pulmonary, dermatologic, gastroenterologic, ophthalmologic, ENT, thoracic, and oral/maxillofacial surgery. Also indicated for skin resurfacing and wrinkle 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

• Schwartz Electro-Optics, Inc. CRL 2940 Erbium CrystaLase
• Continuum Biomedical CB Erbium/2.94

Submission Summary (Full Text)

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K974039

## JAN 1 2 1998

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS: VIII.

From a technology perspective, theory of operation the predicate device is the same as the Schwartz Electro-Optics, Inc. CRL 2940 Erbium CrystaLase. The laser mediums are the same, the systems are similar both mechanically and electronically. Schwartz Electro-Optics, Inc. believes that the technological characteristics of the CLR 2940 are similar to the predicate device, the Continuum Biomedical CB Erbium/2.94.

In regards to safety and effectiveness of the Schwartz Electro-Optics, Inc. CLR 2940 Erbium Laser, 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 Safe Advisory: 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.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 2 1998

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

K974039 Re:

Trade Name: Schwartz Electro-Optics, Inc. CLR 2940 Erbium CrystaLase Regulatory Class: II Product Code: GEX Dated: October 16, 1997 Received: October 16, 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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Page 2 - Mr. Shea

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.

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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# k974039

**Food and Drug Administration**

Office of Device Evaluation Document Mail Center (HFZ - 401) 9200 Corporate Boulevard Rockville, Maryland 20850

Oct 16 10 54 AM '97

FDA/CDRH/ODE/DMC

**Reference: K071404**

## Indication for Use

As previously cleared, the Schwartz Electro-Optics, Inc. CLR 2940 is indicated for use in small and large joint Arthroscopy, including laparoscopic procedures, general and all surgical procedures for cutting (incision), vaporizing, ablating and coagulating soft tissue and cartilage. All soft tissues encountered in all surgical procedures are included in this indication such as, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The CLR 2940 may also be used for skin resurfacing and the treatment of wrinkles.

Specialties are:

- * General Surgery
- * Plastic Surgery,
- * Podiatry
- * Urology
- * Gynecology
- * Pulmonary Surgery
- * Dermatology
- * Gastroenterology
- * Ophthalmology
- * ENT
- * Thoracic Surgery
- * Oral and Maxillofacial Surgery

These indications have been cleared for marketing by the Food and Drug Administration for the cited predicated lasers. Schwartz Electro-Optics, Inc. is simply requesting the addition of skin resurfacing and the treatment of wrinkles.

| Prescription Use | _____________________________________________________________________________________________________________________________________________________________ |
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| (Per 21 CFR 801.109) | |