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Polaris, Oral Indication

by Pfizer Laser Systems

510(k) K912063

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 NumberK912063 Date16 Oct 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  • Withdrawn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, 25 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 Polaris, Oral Indication is a powered laser surgical instrument. It is classified under product code GEX and falls within the medical specialty of general and plastic surgery.

This device received FDA 510(k) clearance (K912063) on October 16, 1991, and was found substantially equivalent to a predicate device. It is manufactured by Pfizer Laser Systems and is intended for use in general and plastic surgery procedures.

Other devices from Pfizer Laser Systems

See all devices from Pfizer Laser Systems →

Questions

AI-generated answers, 25 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 Polaris, Oral Indication used for?

    The Polaris, Oral Indication is a powered laser surgical instrument intended for use in general and plastic surgery procedures, as indicated in its FDA 510(k) clearance documentation.

  • What regulatory pathway was used for the Polaris, Oral Indication?

    The device received FDA 510(k) clearance under K912063 on October 16, 1991, and was determined to be substantially equivalent to a predicate device, which is the basis for its market authorization.

  • Who manufactures the Polaris, Oral Indication and where is it located?

    The Polaris, Oral Indication is manufactured by Pfizer Laser Systems, located at 3 Morgan, Irvine, CA 92718, United States, as listed in the device’s authorization records.