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Apollo

by Pollogen Ltd

510(k) K111026

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK111026 Date16 Nov 2011ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
GEI
FDA applicant
Pollogen, Ltd.
Device class
Class II
Regulation
21 CFR Part 878.4400
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Apollo TriPollar RF is a third-generation radiofrequency (RF) device designed for non-invasive facial and body contouring. It employs TriPollar technology, which distributes RF energy between three or more electrodes to target treatment areas precisely, promoting skin tightening, fat reduction, and cellulite reduction. This modality is intended for aesthetic applications in soft tissue remodeling without surgical intervention. The device operates by delivering controlled thermal energy to stimulate collagen production and improve tissue density.

The Apollo TriPollar RF is supplied as a reusable medical device intended for professional use in clinical or aesthetic settings. It is not sterile upon delivery and requires sterilization or disinfection between uses as per manufacturer guidelines. The device is classified under FDA product code GEI (General & Plastic Surgery) and has received FDA 510(k) clearance (K111026) through the Traditional pathway. Compliance with regulatory standards ensures safe operation within approved indications, adhering to FDA-substantiated equivalence claims.

Devices cleared under K111026

3 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K111026
UDI-DISize and differences
POLLOGEN LEGEND+
POLLOGEN LTD
20900270 / POLLOGEN LEGEND+07290016586015 —On the market
POLLOGEN LEGEND+
POLLOGEN LTD
21400270 / POLLOGEN LEGEND+07290016586022 —On the market
POLLOGEN LEGEND+
POLLOGEN LTD
21400370 / POLLOGEN LEGEND+07290016586039 —On the market

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 →