Apollo
by Pollogen Ltd
510(k) K111026
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK111026 | Date16 Nov 2011 | StatusActive |
Official records
- FDA 510(k) database K111026
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
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
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.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| POLLOGEN LEGEND+ | 20900270 / POLLOGEN LEGEND+ | 07290016586015 | — | On the market |
| POLLOGEN LEGEND+ | 21400270 / POLLOGEN LEGEND+ | 07290016586022 | — | On the market |
| POLLOGEN LEGEND+ | 21400370 / POLLOGEN LEGEND+ | 07290016586039 | — | On the market |
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