ID-500 iRestore Hair Growth System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K213094 FDA 510(k)
- FDA Product Code
- OAP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5500 FDA 510(k)
- Regulation Number
- 890.5500 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ID-500 iRestore Hair Growth System is a low-level laser therapy device designed for hair growth promotion. It employs laser comb technology to deliver targeted laser energy to the scalp, stimulating hair follicles to encourage regrowth in individuals experiencing thinning or loss. Classified as a laser comb for hair, it adheres to FDA-substantiated equivalence standards for physical medicine applications.
This device is supplied as a non-prescription solution for home use, including a laser dome, power adapter, remote control, and user manual. It is classified as a Class II medical device and has received FDA 510(k) clearance. The system is non-sterile and reusable, with no specific MRI safety restrictions. No additional storage or handling requirements beyond standard household conditions are specified.
ID-500 iRestore Hair Growth System
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: IRestore ID-500 Laser Hair Growth System User manual, iRestore Laser Hair Growth System - User Manual (ID-500), IRESTORE ID-500 USER MANUAL Pdf Download | ManualsLib, IRESTORE HAIR GROWTH SYSTEM USER MANUAL Pdf Download
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213094 | Class II | Active |
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Manufacturer
- Manufacturer
- Freedom Laser Therapy, Inc.
Sources (1)
- FDA 510(k) K213094 24 fields · synced Oct 5, 2026