neoV NeoV1064

by G.N.S Neolaser Ltd 3 variants

neoV NeoV1064 (BG16400) is a Class II device made by G.N.S Neolaser Ltd, cleared under FDA 510(k) K133006 on 17 Apr 2014 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 07290016629064), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number07290016629064 UDI-DI	Date1 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK133006	Date17 Apr 2014Decided	StatusActive

Official records

AccessGUDID record UDI-DI 07290016629064
FDA 510(k) database 510(k) number K133006

Across registries

2 registries list this device

FDA 510(k) K133006 decided 17 Apr 2014 Active
FDA GUDID UDI-DI 07290016629064 listed 1 Sep 2016 Listed

Timeline

2 dated events

17 Apr 2014 Cleared FDA 510(k) K133006
1 Sep 2016 Listed FDA GUDID 07290016629064

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: neoV
Generic name: General/multiple surgical diode laser system
Model / Ref / Catalog: NeoV1064, BG16400

Primary DI / UDI-DI: 07290016629064
510(k) Number: K133006
FDA product code: GEX
GMDN term: General/multiple surgical diode laser system

Device class: Class II
Regulation number: 878.4810
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Serial number
Manufacturing date

Other properties (12, all answered No)