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Diode laser device (BM091)

by Hebei Newangie Technology Co., Ltd.

510(k) K251801

Diode laser device (BM091) is a medical device (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Hebei Newangie Technology Co., Ltd., cleared under FDA 510(k) K251801 on 8 Aug 2025, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK251801 Date8 Aug 2025ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
GEX
Device class
Class II
Regulation
21 CFR Part 878.4810
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

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

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

Similar devices

Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).

Other devices from Hebei Newangie Technology Co., Ltd.