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Geneo X Elite

by Pollogen Ltd 2 variants

510(k) K242227

Geneo X Elite is a medical device (FDA Class II; FDA product code PAY, Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction) made by Pollogen Ltd, cleared under FDA 510(k) K242227 on 12 Oct 2025, active as of 22 Oct 2026.

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 NumberK242227 Date12 Oct 2025ClearedStatusActive

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  • Withdrawn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
PAY
FDA applicant
Pollogen, Ltd.
Device class
Class II
Regulation
21 CFR Part 878.4420
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code PAY (Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction).

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