InMode AG606992A

by Inmode MD, Ltd.

InMode AG606992A is a Class II device made by Inmode MD, Ltd., cleared under FDA 510(k) K180719 on 14 Jun 2018 (2 earlier submissions) and listed in FDA GUDID since 26 Oct 2022 (UDI-DI 07290016633382), 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	GUDID listing	Number07290016633382 UDI-DI	Date26 Oct 2022Listed	StatusListed GUDID: in commercial distribution
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	NumberK173677	Date23 Feb 2018Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK170738	Date7 Aug 2017Decided	StatusActive

Official records

AccessGUDID record UDI-DI 07290016633382
FDA 510(k) database 510(k) number K180719
FDA 510(k) database 510(k) number K173677
FDA 510(k) database 510(k) number K170738

Across registries

2 registries list this device

FDA 510(k) K180719 decided 14 Jun 2018 Active· +2 more in the status table
FDA GUDID UDI-DI 07290016633382 listed 26 Oct 2022 Listed

Timeline

4 dated events

7 Aug 2017 Cleared FDA 510(k) K170738
23 Feb 2018 Cleared FDA 510(k) K173677
14 Jun 2018 Cleared FDA 510(k) K180719
26 Oct 2022 Listed FDA GUDID 07290016633382

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Withdrawn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: AG606992A

Primary DI / UDI-DI: 07290016633382
510(k) Number: K170738
K173677
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)