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Picasso Pro Pre-initiated Laser Tip, 400um, 5mm 05380

by Cao Group, Inc.

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 Number00872320006877 UDI-DI Date10 Apr 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  • Withdrawn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
Picasso Pro Pre-initiated Laser Tip, 400um, 5mm
Generic Name
Dental diode laser system
Model / Reference
05380
Primary DI / UDI-DI
00872320006877
510(k) Number
FDA Product Code
GEX, NVK
GMDN Term
Dental diode laser system
Device Class
Class II
Regulation Number
878.4810
GUDID distribution status
In Commercial Distribution
Sterilization Method
Liquid Chemical
Size
Width — 400 Micrometer
Length — 5 Millimeter

Related devices

Cleared under the same submission (K254197)

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No