Identifiers
- 510(k) Number
- K101573 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 AccuSculpt II Laser System is a surgical Nd:YAG laser console designed for soft tissue procedures. It employs laser energy for precise tissue modification, including laser-assisted lipolysis, and integrates an optical fiber delivery system, handpiece, footswitch, and embedded processor for controlled application.
This device is intended for use in clinical settings by physicians and is supplied as a reusable system. It operates on a power supply of 230 V with a frequency of 50/60 Hz and a power rating of 3000 VA. The system holds an FDA 510(k) clearance under the product code GEX, classified under General Plastic Surgery, with a decision date of September 23, 2010.
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: ACCUSCULPT II LASER SYSTEM (K101573) — FDA 510(k) | Innolitics, ACCUSCULPT II by Lutronic - Komachine Supplier Profile and Product List, LUTRONIC ACCUSCULPT II - Med-Get
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K101573 | Class II | Active |
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Manufacturer
- Manufacturer
- Lutronic Corporation
Sources (1)
- FDA 510(k) K101573 24 fields · synced Sep 19, 2026