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UltraSmooth Digital 60009

by Photonica USA LLC

UltraSmooth Digital 60009 is a Class II device made by Photonica USA LLC, cleared under FDA 510(k) K202361 on 18 Dec 2020 and listed in FDA GUDID since 4 Jan 2021 (UDI-DI 00860925000345), 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) K202361

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 Number00860925000345 UDI-DI Date4 Jan 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK202361 Date18 Dec 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K202361 decided 18 Dec 2020 Active
  • FDA GUDID UDI-DI 00860925000345 listed 4 Jan 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K202361
  2. Listed FDA GUDID 00860925000345

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
UltraSmooth Digital
Generic name
Low-intensity laser fat liquefaction system, mobile
Model / Ref / Catalog
60009
Primary DI / UDI-DI
00860925000345
510(k) Number
FDA product code
OLI
GMDN term
Low-intensity laser fat liquefaction system, mobile
Device class
Class II
Regulation number
878.5400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Low-intensity laser fat liquefaction system

Cleared under the same submission (K202361)

Similar devices

Other devices filed under FDA product code OLI (Fat Reducing Low Level Laser).

Other devices from Photonica USA LLC

Properties

  • Prescription use
Other properties (14, all answered No)