Inmode Hair Removal (HR) Device
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K123682 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Inmode Hair Removal (HR) device is a laser-based system indicated for use in hair removal. It is substantially equivalent to the LightSheer and Leda EPI 808 predicate devices in design and components, and is classified under product code GEX for general and plastic surgery applications.
The device received FDA 510(k) clearance via the traditional pathway on February 27, 2013, under K-number K123682. It is manufactured by Inmode MD, Ltd., located in Kfar Saba, Israel, and is intended for use in clinical settings for hair reduction on various skin types.
Frequently asked questions
What is the Inmode Hair Removal (HR) device used for?
The Inmode Hair Removal (HR) device is a laser-based system indicated for use in hair removal. It is intended for clinical settings to achieve hair reduction on various skin types, based on its substantial equivalence to predicate devices like LightSheer and Leda EPI 808.
How was the Inmode Hair Removal (HR) device cleared for market?
The device received FDA 510(k) clearance via the traditional pathway on February 27, 2013, under K-number K123682. It was determined to be substantially equivalent to the LightSheer and Leda EPI 808 predicate devices in design and components, and is classified under product code GEX for general and plastic surgery applications.
Who manufactures the Inmode Hair Removal (HR) device and where is it made?
The Inmode Hair Removal (HR) device is manufactured by Inmode MD, Ltd., located at 20 Hata'As St., Suite 102, Kfar Saba, Israel, with postal code 44425. The applicant and manufacturer are the same entity, as listed in the FDA 510(k) submission.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: INMODE HAIR REMOVAL (HR) DEVICE (K123682) — FDA 510 (k) | Innolitics, Laser Hair Removal Solutions | InMode, InMode - Advanced Medical Aesthetic Technology, PDF K123682 - Inmode Hair Removal (Hr) Device, PDF FB2 2013 - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K123682 | Class II | Active |
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Manufacturer
- Manufacturer
- Inmode MD , Ltd.
Sources (1)
- FDA 510(k) K123682 24 fields · synced Sep 26, 2026