← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K980559

# PEGASUS ND:YAG LASER SYSTEM (K980559)

_Premier Laser Systems, Inc. · GEX · Aug 24, 1998 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K980559

## Device Facts

- **Applicant:** Premier Laser Systems, Inc.
- **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md)
- **Decision Date:** Aug 24, 1998
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4810
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
- **Attributes:** Therapeutic

## Intended Use

Pulpotomy Pulpotomy as an adjunct to root canal therapy

## Device Story

Pegasus Nd:YAG Laser System is a dental laser device used by dentists for pulpotomy and as an adjunct to root canal therapy. The device utilizes Nd:YAG laser energy to perform soft tissue procedures. It is operated by a clinician in a dental office setting. The laser output is used to treat dental pulp tissue, facilitating endodontic treatment. 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

Nd:YAG laser system; energy source is a laser diode/crystal; device is a Class II medical device (Product Code: GEX).

## Regulatory 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

- [K905082](/device/K905082.md)

## Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol resembles an abstract human figure or a bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 24 1998

Mr. Jeff Anderson Vice President Regulatory Affairs/Quality Assurance Premier Laser Systems, Inc. 3 Morgan Irvine, California 92618

Re: K980559

Trade Name: Pegasus Nd: YAG Laser System Regulatory Class: II Product Code: GEX Dated: May 18, 1998 Received: May 26, 1998

Dear Mr. Anderson:

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

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## Page 2 - Mr. Anderson

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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, 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/dsma/dsmamain.html".

Sincerely yours,

V. Lockhart

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

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Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Pegasus Nd: YAG Laser System

Indications for Use:

Pulpotomy

## Pulpotomy as an adjunct to root canal therapy

- This is an additional indication to the indications cleared for market release in 510 NOTE: (k) 905082.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off)                     |         |
|-----------------------------------------|---------|
| Division of General Restorative Devices |         |
| 510(k) Number                           | K990554 |

| Prescription Use (Per 21 CFR 801.109) | X | Or | Over-The-Counter Use |
|---------------------------------------|---|----|----------------------|
|---------------------------------------|---|----|----------------------|

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K980559](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K980559)

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