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Centauri/Pegasus

by Pfizer Laser Systems 2 variants

510(k) K905737

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK905737 Date17 Jun 1991ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEX
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Centauri/Pegasus is a powered laser surgical instrument classified under the GEX product code. It is designed for use in general and plastic surgery procedures.

This device is a Class II medical device with special controls, cleared by the FDA through a traditional 510(k) process. The Centauri/Pegasus is supplied by Pfizer Laser Systems and was granted FDA clearance in 1991.

Other devices from Pfizer Laser Systems

See all devices from Pfizer Laser Systems →

Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Centauri/Pegasus device used for?

    The Centauri/Pegasus is a powered laser surgical instrument designed specifically for use in general and plastic surgery procedures. It is classified under the GEX product code and is intended for surgical applications where laser technology is beneficial.

  • How is the Centauri/Pegasus supplied and what is its regulatory status?

    The Centauri/Pegasus is supplied by Pfizer Laser Systems and is a Class II medical device with special controls. It was granted FDA clearance through a traditional 510(k) process in 1991, with the K number K905737, making it substantially equivalent to other devices in its class.

  • Is the Centauri/Pegasus a single-use or reusable device?

    The device data does not specify whether the Centauri/Pegasus is designed for single-use or multiple reuse. This information would typically be found in the device's instructions for use or labeling materials, which are not provided in the current data.

  • What are the available sizes or models of the Centauri/Pegasus?

    The provided device data does not specify different sizes or models for the Centauri/Pegasus. The information only indicates it is a powered laser surgical instrument under the GEX product code, without detailing variations in size, model numbers, or configurations.