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ORION

by Pfizer Laser Systems 2 variants

510(k) K911288

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 NumberK911288 Date16 Nov 1993ClearedStatusActive

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  • Withdrawn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, 27 Sep 2026

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

ORION is a YAG laser system intended for general and plastic surgery applications. It is a medical device that uses laser technology for surgical procedures.

ORION was cleared by the FDA through the 510(k) process under K911288 on November 16, 1993. It is manufactured by Pfizer Laser Systems and classified under product code GEX. The device is supplied as a reusable system for use in clinical settings.

Other devices from Pfizer Laser Systems

See all devices from Pfizer Laser Systems →

Questions

AI-generated answers, 27 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 ORION laser system used for?

    The ORION laser system is intended for general and plastic surgery applications, using YAG laser technology to perform surgical procedures in clinical settings.

  • Is the ORION laser system reusable or single-use?

    The ORION laser system is supplied as a reusable system, meaning it is designed for multiple uses after proper cleaning and maintenance in accordance with manufacturer guidelines.

  • Who manufactures the ORION laser system and when was it cleared?

    The ORION laser system is manufactured by Pfizer Laser Systems and received FDA 510(k) clearance under K911288 on November 16, 1993.