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Supra 577Y

by Quantel Medical

Supra 577Y is a Class II device made by Quantel Medical, cleared under FDA 510(k) K091581 on 16 Jun 2009 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 03700542625316), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K091581

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03700542625316 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK091581 Date16 Jun 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K091581 decided 16 Jun 2009 Active
  • FDA GUDID UDI-DI 03700542625316 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K091581
  2. Listed FDA GUDID 03700542625316

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Ophthalmic diode laser system
Model / reference
SUPRA 577Y
Primary DI / UDI-DI
03700542625316
510(k) Number
FDA product code
HQF
GMDN term
Ophthalmic diode laser system
Device class
Class II
Regulation number
886.4390
GUDID distribution status
In Commercial Distribution

Related devices

Category: Ophthalmic diode laser system

Cleared under the same submission (K091581)

and 2 more cleared under K091581

Similar devices

Other devices filed under FDA product code HQF (Laser, Ophthalmic).

Other devices from Quantel Medical

See all devices from Quantel Medical →

Properties

  • Serial number
Other properties (14, all answered No)