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OMNIPULSE HOLMIUM LASER SYSTEM - Omnipulse Max Holmium Laser System, Model 1210-Vhp And 1500-A
FDA 510(k)Class II (US FDA 510(k))
510(k) K002308
Identifiers
- 510(k) Number
- K002308 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
- Models / Variants
- Omnipulse Holmium Laser System, Model 1210 FDA 510(k)Omnipulse Max Holmium Laser System, Model 1210-Vhp And 1500-A 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)
OMNIPULSE HOLMIUM LASER SYSTEM - Omnipulse Max Holmium Laser System, Model 1210-Vhp And 1500-A by Trimedyne, Inc. — Class II — FDA_510K — listed in FDA 510(k)…
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 | K002308 | Class II | Active |
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Manufacturer
- Manufacturer
- Trimedyne, Inc.
Sources (1)
- FDA 510(k) K002308 24 fields · synced Jun 18, 2026