Skip to content

Medical Diode Laser Systems

by Wuhan Gigaa Optronics Technology Co., Ltd.

510(k) K151890Ref GA.02.006.EN, GA.02.003.EN, GA.02.005.ENModel VELASⅡ-60B, VELASⅡ-30B, VELASⅡ-60A

Active European Union and United States

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K151890↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06974632230323 Basic UDI-DI Date22 May 2026RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK151890 Date23 Dec 2015ClearedStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-06974632230323 registered 22 May 2026 Active
  • FDA 510(k) K151890 decided 23 Dec 2015 Active

Timeline

2 dated events

  1. Cleared FDA 510(k) K151890
  2. Registered EUDAMED B-06974632230323

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Model / reference
VELASⅡ-60B, GA.02.006.EN, VELASⅡ-30B, GA.02.003.EN, VELASⅡ-60A, GA.02.005.EN
Primary DI / UDI-DI
06974632230323, 06974632230224, 06974632230330
Basic UDI-DI
B-06974632230323, B-06974632230224, B-06974632230330
510(k) Number
FDA product code
GEX
EMDN code
Z12011016 Diode surgical laser
Device class
Class IIb EUDAMED
Class II 510(k)
Regulation
21 CFR Part 878.4810
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device classEUDAMED
Class IIb
510(k)
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA 510(k)). EU and US classes are different schemes, so this is not a disagreement.

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 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 Medical Diode Laser Systems are classified as Diode Lasers (Device Type: GEX) and are designed for surgical and cosmetic applications in general and plastic surgery. These systems emit coherent light at specific wavelengths to perform procedures such as tissue ablation, coagulation, and vaporisation, leveraging the precision of diode laser technology for controlled medical interventions.

These systems are supplied by Wuhan Gigaa Optronics Technology Co., Ltd., and are intended for use in clinical settings where sterile conditions are required. They are regulated under the FDA’s 510(k) pathway, with a clearance decision dated December 23, 2015, and comply with the Medical Device Directive (MDD). No specific sterility or single-use/reusable designation is stated in the data, though typical laser systems in surgery are often used in sterile environments.

Devices cleared under K151890

7 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K151890
UDI-DISize and differences
GIGAA GBOX-15A
Wuhan Gigaa Optronics Technology Co., Ltd.
GBOX-15A06970460900018 —On the market
GIGAA GBOX-15B
Wuhan Gigaa Optronics Technology Co., Ltd.
GBOX-15B06970460900025 —On the market
GIGAA VELASⅡ-30A
Wuhan Gigaa Optronics Technology Co., Ltd.
VELASⅡ-30A06970460900032 —On the market
GIGAA VELASⅡ-30B
Wuhan Gigaa Optronics Technology Co., Ltd.
VELASⅡ-30B06970460900049 —On the market
GIGAA VELASⅡ-60A
Wuhan Gigaa Optronics Technology Co., Ltd.
VELASⅡ-60A06970460900056 —On the market
GIGAA VELASⅡ-60B
Wuhan Gigaa Optronics Technology Co., Ltd.
VELASⅡ-60B06970460900063 —On the market
GIGAA VELASⅡ-60C
Wuhan Gigaa Optronics Technology Co., Ltd.
VELASⅡ-60C06970460900070 —On the market

Similar devices in this category

Other devices filed under DIODE SURGICAL LASER.

Other devices from Wuhan Gigaa Optronics Technology Co., Ltd.

See all devices from Wuhan Gigaa Optronics Technology Co., Ltd. →

Properties

  • Reusable
Other properties (11, all answered No)