Identifiers
- 510(k) Number
- K212790 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 XLase Plus is a laser device (Product Code: GEX) designed for use in plastic surgery, delivering precise tissue ablation and resurfacing through advanced laser technology. It is classified under the FDA’s General, Plastic Surgery advisory committee and is intended for controlled laser applications in dermatological and aesthetic procedures.
Supplied as a traditional 510(k) cleared device (FDA K212790), the XLase Plus is manufactured by Biotec Italia Srl and distributed from Dueville, Italy. It is intended for single-use or reusable settings, depending on clinical protocol, with no explicit MRI safety restrictions noted in the data. Storage and handling must comply with standard laser device protocols, and its modular design supports multiple application modules.
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: Xlase Plus - Biotec Italia, Xlase Plus - Biotec Italia, xlase-promo, Laser - XLASE PLUS - Biotec Italia - MedicalExpo
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212790 | Class II | Active |
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Manufacturer
- Manufacturer
- Biotec Italia, Srl
Sources (1)
- FDA 510(k) K212790 24 fields · synced Sep 19, 2026