InMode AG606991A

by Inmode MD, Ltd.

InMode AG606991A is a Class II device made by Inmode MD, Ltd., cleared under FDA 510(k) K180719 on 14 Jun 2018 (9 earlier submissions) and listed in FDA GUDID since 27 Apr 2017 (UDI-DI 07290016633375), 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

+9 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 · Traditional	NumberK180719	Date14 Jun 2018Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK180189	Date1 Jun 2018Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK173677	Date23 Feb 2018Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK172302	Date8 Dec 2017Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK170738	Date7 Aug 2017Decided	StatusActive
United States	GUDID listing	Number07290016633375 UDI-DI	Date27 Apr 2017Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK160329	Date19 Aug 2016Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK151273	Date4 Jan 2016Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK140926	Date3 Dec 2014Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK131362	Date8 Oct 2013Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK123682	Date27 Feb 2013Decided	StatusActive

Official records

AccessGUDID record UDI-DI 07290016633375
FDA 510(k) database 510(k) number K180719
FDA 510(k) database 510(k) number K180189
FDA 510(k) database 510(k) number K173677
FDA 510(k) database 510(k) number K172302
FDA 510(k) database 510(k) number K170738
FDA 510(k) database 510(k) number K160329
FDA 510(k) database 510(k) number K151273
FDA 510(k) database 510(k) number K140926
FDA 510(k) database 510(k) number K131362
FDA 510(k) database 510(k) number K123682

Across registries

2 registries list this device

FDA 510(k) K180719 decided 14 Jun 2018 Active· +9 more in the status table
FDA GUDID UDI-DI 07290016633375 listed 27 Apr 2017 Listed

Timeline

11 dated events

8 Oct 2013 Cleared FDA 510(k) K131362
3 Dec 2014 Cleared FDA 510(k) K140926
4 Jan 2016 Cleared FDA 510(k) K151273
19 Aug 2016 Cleared FDA 510(k) K160329
27 Apr 2017 Listed FDA GUDID 07290016633375
7 Aug 2017 Cleared FDA 510(k) K170738
8 Dec 2017 Cleared FDA 510(k) K172302
23 Feb 2018 Cleared FDA 510(k) K173677
1 Jun 2018 Cleared FDA 510(k) K180189
14 Jun 2018 Cleared FDA 510(k) K180719

1 earlier event are in the sections above.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: InMode
Generic name: Multi-modality skin surface treatment system
Model / Ref / Catalog: AG606991A

Primary DI / UDI-DI: 07290016633375
510(k) Number: K123682
K131362
K140926
K151273
K160329
K170738
K172302
K173677
K180189
K180719
FDA product code: GEX
GMDN term: Multi-modality skin surface treatment system

Device class: Class II
Regulation number: 878.4810
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Serial number
Manufacturing date

Other properties (12, all answered No)