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Applicator 2 20900350BK

by Pollogen Ltd

Applicator 2 20900350BK is a Class II device made by Pollogen Ltd, cleared under FDA 510(k) K252576 on 12 Sep 2025 and listed in FDA GUDID since 2 Feb 2026 (UDI-DI 07290016586787), 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) K252576

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 Number07290016586787 UDI-DI Date2 Feb 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK252576 Date12 Sep 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K252576 decided 12 Sep 2025 Active
  • FDA GUDID UDI-DI 07290016586787 listed 2 Feb 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K252576
  2. Listed FDA GUDID 07290016586787

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Applicator 2
Generic name
Radio-frequency skin surface treatment system applicator
Model / reference
20900350BK
Primary DI / UDI-DI
07290016586787
510(k) Number
FDA product code
GEI, NGX
GMDN term
Radio-frequency skin surface treatment system applicator
Device class
Class II
Regulation number
878.4400, 890.5850
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K252576)

Similar devices

Other devices filed under FDA product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Other devices from Pollogen Ltd

See all devices from Pollogen Ltd →

Properties

  • Convenience kit
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)