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Optimis II

by Quantel Medical

Optimis II is a Class II device made by Quantel Medical, cleared under FDA 510(k) K043613 on 24 Mar 2005 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 03700542625279), active as of 8 Jun 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 8 Jun 2026

Documents

510(k) K043613

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Jun 2026.

Regulatory status

as of registry sync 8 Jun 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03700542625279 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK043613 Date24 Mar 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K043613 decided 24 Mar 2005 Active
  • FDA GUDID UDI-DI 03700542625279 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K043613
  2. Listed FDA GUDID 03700542625279

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Ophthalmic solid-state laser system, photodisruption
Model / reference
OPTIMIS II
Description
1064nm Q-Switched Nd:YAG Laser Cataract and Glaucoma laser
Primary DI / UDI-DI
03700542625279
510(k) Number
FDA product code
HQF
GMDN term
Ophthalmic solid-state laser system, photodisruption
Device class
Class II
Regulation number
886.4390
GUDID distribution status
In Commercial Distribution

Related devices

Category: Ophthalmic solid-state laser system, photodisruption

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)