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Bvlaser Lk-Pt

by Nanjing Bestview Laser S&T Co., Ltd.

Bvlaser Lk-Pt is a Class II device made by Nanjing Bestview Laser S&T Co., Ltd., cleared under FDA 510(k) K242440 on 14 Nov 2024 and listed in FDA GUDID since 27 Nov 2024 (UDI-DI 06974851083014), active as of 22 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 22 Oct 2026

Documents

510(k) K242440

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06974851083014 UDI-DI Date27 Nov 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK242440 Date14 Nov 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K242440 decided 14 Nov 2024 Active
  • FDA GUDID UDI-DI 06974851083014 listed 27 Nov 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K242440
  2. Listed FDA GUDID 06974851083014

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Bvlaser
Generic name
Intense pulsed light skin surface treatment system
Model / reference
LK-PT
Primary DI / UDI-DI
06974851083014
510(k) Number
FDA product code
ONF
GMDN term
Intense pulsed light skin surface treatment system
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect).

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  • BVLASER Monica-I

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See all devices from Nanjing Bestview Laser S&T Co., Ltd. →

Properties

  • Serial number
  • Expiration date
Other properties (13, all answered No)