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BVLASER Monica-II

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

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06974851082086 UDI-DI Date16 Jul 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Bvlaser
Generic Name
General/multiple surgical carbon dioxide laser system
Model / Reference
Monica-II
Primary DI / UDI-DI
06974851082086
510(k) Number
FDA Product Code
GEX
GMDN Term
General/multiple surgical carbon dioxide laser system
Device Class
Class II
Regulation Number
878.4810
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Cleared under the same submission (K260974)

Other devices from Nanjing Bestview Laser S&T Co., Ltd.

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

Properties

  • Prescription Use
  • Serial Number
  • Expiration Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Manufacturing Date: No