Identifiers
- 510(k) Number
- K193426 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 Elite iQ is a laser-based device classified under the nomenclature for aesthetic and cosmetic skin treatments, specifically for non-ablative skin resurfacing and hair removal. It delivers controlled laser energy to target pigmented lesions, vascular lesions, and hair follicles, promoting tissue remodeling and hair reduction without damaging the epidermis.
This device is supplied as a reusable medical instrument, intended for use in clinical settings such as dermatology and plastic surgery offices. It is not sterile upon packaging and must be sterilized before use, adhering to standard medical device sterilization protocols. The Elite iQ operates under FDA 510(k) clearance (K193426) and complies with the Medical Device Directive (MDD), with no third-party involvement in its regulatory 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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K193426 | Class II | Active |
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Manufacturer
- Manufacturer
- Cynosure, LLC
Sources (2)
- FDA 510(k) K193426 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026