Envision System AG609993A

by Inmode MD, Ltd.

Envision System AG609993A 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 24 Mar 2024 (UDI-DI 07290016633726), 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	Number07290016633726 UDI-DI	Date24 Mar 2024Listed	StatusListed GUDID: in commercial distribution
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	NumberK210492	Date12 Jul 2021Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK200293	Date5 May 2020Decided	StatusActive

Official records

AccessGUDID record UDI-DI 07290016633726
FDA 510(k) database 510(k) number K221571
FDA 510(k) database 510(k) number K210492
FDA 510(k) database 510(k) number K200293

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 07290016633726 listed 24 Mar 2024 Listed

Timeline

4 dated events

5 May 2020 Cleared FDA 510(k) K200293
12 Jul 2021 Cleared FDA 510(k) K210492
30 Jun 2022 Cleared FDA 510(k) K221571
24 Mar 2024 Listed FDA GUDID 07290016633726

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Envision System
Generic name: Multi-modality skin surface treatment system
Model / Ref / Catalog: AG609993A

Primary DI / UDI-DI: 07290016633726
510(k) Number: K200293
K210492
K221571
FDA product code: GEX, GEI, ONF, NUV, ISA, PBX
GMDN term: Multi-modality skin surface treatment system

Device class: Class II
Regulation number: 878.4810, 878.4400, 890.5660
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Serial number
Manufacturing date

Other properties (12, all answered No)