UNIPULSE CO2 SURGICAL LASER SYSTEM

K980475 · Nidek, Inc. · GEX · Dec 16, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K980475
• Device Name: UNIPULSE CO2 SURGICAL LASER SYSTEM
• Applicant: Nidek, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Nideks UniPulse CO2 Laser System is intended for all cleared Coherent CO2 skin resurfacing applications. Plastic Surgery and Dermatology: UniPulse CO2 Surgical Laser Systems are intended for skin resurfacing for the treatment of wrinkles, rhytids, furrows and acne scar revision.

Device Story

UniPulse CO2 Surgical Laser System is a CO2 laser device used in plastic surgery and dermatology. It delivers laser energy to skin tissue to perform resurfacing procedures. Operated by clinicians in a clinical setting, the device is used to treat wrinkles, rhytids, furrows, and acne scars. The system functions by ablating or vaporizing targeted skin layers, allowing for skin rejuvenation. The healthcare provider uses the laser to precisely remove damaged tissue, which promotes healing and improves skin texture. The device is intended for prescription use only.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to the predicate device.

Technological Characteristics

CO2 surgical laser system; Class II device. Complies with 21 CFR 1040.10 and 1040.11 performance standards for medical laser products. System utilizes CO2 laser technology for tissue ablation.

Indications for Use

Indicated for plastic surgery and dermatology patients requiring skin resurfacing for treatment of wrinkles, rhytids, furrows, and acne scar revision.

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

• Coherent CO2 laser system

Submission Summary (Full Text)

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K980475

DEC 16 1998

## SUMMARY OF SAFETY AND EFFECTIVENESS NIDEK UNIPULSE CO2 SURGICAL LASER SYSTEM

#### REGULATORY AUTHORITY:

Safe Medical Devices Act of 1990, 21 CFR 807.92

#### COMPANY NAME/CONTACT:

Ken Kato Vice President 47651 Westinghouse Drive Fremont, CA 94539 Phone: [phone] Fax: [phone]

DEVICE TRADE NAME:

UniPulse CO2 Laser System

DEVICE COMMON NAME:

CO2 Surgical Laser System

#### DEVICE CLASSIFICATION:

CO2 laser systems are classified as Class II.

#### PERFORMANCE STANDARDS:

The laser systems manufactured by Nidek Inc. comply with 21 CFR 1040.10 and 1040.11, FDA regulations for medical laser products, as applicable.

INDICATIONS FOR USE STATEMENT:

Nideks UniPulse CO2 Laser System is intended for all cleared Coherent CO2 skin resurfacing applications.

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# COMPARISON WITH PREDICATE DEVICE:

The Nidek CO2 system is substantially equivalent to Coherent's CO2 laser system.

The risks and benefits of the Nidek UniPulse CO2 are comparable to the predicate device when used for similar clinical applications.

Since the Nidek UniPulse CO2 laser system is substantially equivalent with respect to indications for use, materials, method of operation and physical construction to the predicate device, we believe it clearly meets the requirement for substantial equivalence according to 510(k) guidelines. Safety and effectiveness are reasonably assured, therefore justifying 510(k) clearance for commercial sale.

86

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Image /page/2/Picture/1 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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 16 1998

Mr. Ken Kato Vice President of Administration Nidek, Incorporated 47651 Westinghouse Drive Fremont, California 94539

K980475 Re:

> Trade Name: UniPulse CO, Surgical Laser System Regulatory Class: II Product Code: GEX Dated: November 30, 1998 Received: December 1, 1998

Dear Mr. Kato:

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 (OS) 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. Ken Kato

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,

Scalef
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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K980475

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### 510(k) Number (if known): Device Name: Nidek UniPulse CO2 Laser System

Indications for Use: Plastic Surgery and Dermatology: UniPulse CO2 Surgical Laser Systems are intended for skin resurfacing for the treatment of wrinkles, rhytids, furrows and acne scar revision.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sign-Off) (Divisiok (Division of General Restorative Devices (L g g O4 7 S 510(k) Number

Prescription Use (Per 21 CFR 801.109)

OR

Over the Counter Use _