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Engauge 8065750971

by Alcon Laboratories, Inc.

Engauge 8065750971 is a Class II device made by Alcon Laboratories, Inc., listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00380657509713), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00380657509713 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Engauge
Generic name
Ophthalmic laser system beam guide
Model / reference
8065750971
Primary DI / UDI-DI
00380657509713
FDA product code
HQC
GMDN term
Ophthalmic laser system beam guide
Device class
Class II
Regulation number
886.4670
GUDID distribution status
In Commercial Distribution

Related devices

Category: Ophthalmic laser system beam guide

Similar devices in this category

Other devices filed under Ophthalmic laser system beam guide.

Other devices from Alcon Laboratories, Inc.

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)