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Lasertx - Diode Laser & Delivery System
FDA 510(k)Class II (US FDA 510(k))
510(k) K060326
by Prosurg Inc
Identifiers
- 510(k) Number
- K060326 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)
A comprehensive and natural language overview of the LASERTX - DIODE LASER & DELIVERY SYSTEM, including its features, compliance, and potential applications.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K060326 | Class II | Active |
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Manufacturer
- Manufacturer
- Prosurg Inc
- FDA Applicant
- Prosurg, Inc.
Sources (1)
- FDA 510(k) K060326 24 fields · synced Jul 14, 2026