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LightLas 532 LC0013(3W)

by Lightmed Corporation

LightLas 532 LC0013(3W) is a medical device (FDA Class II; FDA product code HQF, Laser, Ophthalmic) made by Lightmed Corporation, cleared under FDA 510(k) K091534 on 18 Sep 2009 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04712826770604), active as of 12 Nov 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 12 Nov 2026

Documents

510(k) K091534

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04712826770604 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK091534 Date18 Sep 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K091534 decided 18 Sep 2009 Active
  • FDA GUDID UDI-DI 04712826770604 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K091534
  2. Listed FDA GUDID 04712826770604

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
LightLas 532
Generic name
General/multiple surgical frequency-doubled solid-state laser system
Model / reference
LC0013(3W)
Primary DI / UDI-DI
04712826770604
510(k) Number
FDA product code
HQF
GMDN term
General/multiple surgical frequency-doubled solid-state laser system
Device class
Class II
Regulation number
886.4390
GUDID distribution status
In Commercial Distribution
Size
Weight — 20 Kilogram

Similar devices

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

Other devices from Lightmed Corporation

See all devices from Lightmed Corporation →

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)