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Plg FS10009

by Formatk Systems Ltd

Plg FS10009 is a Class I device made by Formatk Systems Ltd, cleared under FDA 510(k) K160195 on 15 Apr 2016 and listed in FDA GUDID since 18 Aug 2017 (UDI-DI 07290016681314), active as of 23 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 23 Oct 2026

Documents

510(k) K160195

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290016681314 UDI-DI Date18 Aug 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK160195 Date15 Apr 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K160195 decided 15 Apr 2016 Active
  • FDA GUDID UDI-DI 07290016681314 listed 18 Aug 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K160195
  2. Listed FDA GUDID 07290016681314

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Plg
Generic name
Dermabrasion unit
Model / Ref / Catalog
FS10009
Primary DI / UDI-DI
07290016681314
510(k) Number
FDA product code
GFE
GMDN term
Dermabrasion unit
Device class
Class I
Regulation number
878.4820
GUDID distribution status
In Commercial Distribution

Related devices

Category: Skin abrasion unit

Cleared under the same submission (K160195)

and 8 more cleared under K160195

Similar devices

Other devices filed under FDA product code GFE (Brush, Dermabrasion, Powered).

Other devices from Formatk Systems Ltd

  • R-Sonic

    Class IIa

  • Magma Spark Cart FS80001

    Class I

  • B-Hr FS10006

    Class II

  • Magma FS70000

    Class II

See all devices from Formatk Systems Ltd →

Properties

  • Serial number
Other properties (14, all answered No)