Plus90 AG605906A

by Inmode MD, Ltd.

Plus90 AG605906A is a Class II device made by Inmode MD, Ltd., cleared under FDA 510(k) K221571 on 30 Jun 2022 (2 earlier submissions) and listed in FDA GUDID since 25 Oct 2016 (UDI-DI 07290016633306), 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

+2 more

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK221571	Date30 Jun 2022Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK201150	Date22 Jul 2020Decided	StatusActive
United States	GUDID listing	Number07290016633306 UDI-DI	Date25 Oct 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK153568	Date12 Jul 2016Decided	StatusActive

Official records

AccessGUDID record UDI-DI 07290016633306
FDA 510(k) database 510(k) number K221571
FDA 510(k) database 510(k) number K201150
FDA 510(k) database 510(k) number K153568

Across registries

2 registries list this device

FDA 510(k) K221571 decided 30 Jun 2022 Active· +2 more in the status table
FDA GUDID UDI-DI 07290016633306 listed 25 Oct 2016 Listed

Timeline

4 dated events

12 Jul 2016 Cleared FDA 510(k) K153568
25 Oct 2016 Listed FDA GUDID 07290016633306
22 Jul 2020 Cleared FDA 510(k) K201150
30 Jun 2022 Cleared FDA 510(k) K221571

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Plus90
Generic name: Radio-frequency skin contouring system applicator tip
Model / Ref / Catalog: AG605906A

Primary DI / UDI-DI: 07290016633306
510(k) Number: K153568
K201150
K221571
FDA product code: GEI
GMDN term: Radio-frequency skin contouring system applicator tip

Device class: Class II
Regulation number: 878.4400
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Lot / batch number
Manufacturing date

Other properties (12, all answered No)