Skip to content

Fractora AG601261A

by Inmode MD, Ltd.

Fractora AG601261A is a Class II device made by Inmode MD, Ltd., cleared under FDA 510(k) K102461 on 2 Jun 2011 and listed in FDA GUDID since 25 Oct 2016 (UDI-DI 07290016633054), 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

510(k) K102461

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290016633054 UDI-DI Date25 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK102461 Date2 Jun 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K102461 decided 2 Jun 2011 Active
  • FDA GUDID UDI-DI 07290016633054 listed 25 Oct 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K102461
  2. Listed FDA GUDID 07290016633054

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Fractora
Generic name
Radio-frequency skin surface treatment system applicator
Model / Ref / Catalog
AG601261A
Primary DI / UDI-DI
07290016633054
510(k) Number
FDA product code
GEI
GMDN term
Radio-frequency skin surface treatment system applicator
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Radio-frequency skin surface treatment system applicator

Cleared under the same submission (K102461)

Other devices from Inmode MD, Ltd.

See all devices from Inmode MD, Ltd. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)