BodyTite Pro AG604881A

by Inmode MD, Ltd.

BodyTite Pro AG604881A (AG606972A) is a Class II device made by Inmode MD, Ltd., cleared under FDA 510(k) K233642 on 20 Mar 2024 (4 earlier submissions) and listed in FDA GUDID since 19 May 2024 (UDI-DI 07290016633368), 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

+4 more

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number07290016633368 UDI-DI	Date19 May 2024Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK233642	Date20 Mar 2024Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK182325	Date26 Sep 2018Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK171593	Date10 Oct 2017Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK163190	Date12 Dec 2016Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK151793	Date19 Feb 2016Decided	StatusActive

Official records

AccessGUDID record UDI-DI 07290016633368
FDA 510(k) database 510(k) number K233642
FDA 510(k) database 510(k) number K182325
FDA 510(k) database 510(k) number K171593
FDA 510(k) database 510(k) number K163190
FDA 510(k) database 510(k) number K151793

Across registries

2 registries list this device

FDA 510(k) K233642 decided 20 Mar 2024 Active· +4 more in the status table
FDA GUDID UDI-DI 07290016633368 listed 19 May 2024 Listed

Timeline

6 dated events

19 Feb 2016 Cleared FDA 510(k) K151793
12 Dec 2016 Cleared FDA 510(k) K163190
10 Oct 2017 Cleared FDA 510(k) K171593
26 Sep 2018 Cleared FDA 510(k) K182325
20 Mar 2024 Cleared FDA 510(k) K233642
19 May 2024 Listed FDA GUDID 07290016633368

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: BodyTite Pro
Generic name: Multi-modality skin surface treatment system
Model / Ref / Catalog: AG604881A, AG606972A

Primary DI / UDI-DI: 07290016633368
510(k) Number: K151793
K163190
K171593
K182325
K233642
FDA product code: GEI
GMDN term: Multi-modality skin surface treatment system

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

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Properties

Prescription use
Serial number
Manufacturing date

Other properties (12, all answered No)