COHERENT OPAL PHOTOACTIVATOR LASER SYSTEM
FDA premarket approval P990049 · decided 2000-04-12
Approval details
- PMA number
- P990049
- Trade name
- COHERENT OPAL PHOTOACTIVATOR LASER SYSTEM
- Generic name
- System, laser, photodynamic therapy
- Applicant
- Lumenis
- Date received
- 1999-08-20
- Decision date
- 2000-04-12
- Days to decision
- 236 days
- Decision code
- APWD
- Product code
- MVF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Salt Lake City, UT
- Statement
- Approval for the treatment of age-related macular degeneration in patients with predominantly classic subfoveal choroidal neovascularization.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ACUPULSE 30/40 ST CO2 LASER SYSTEM AND ACUPULSE 40WG CO2 LASER SYSTEM (K100415) | Lumenis | 2010-04-21 |
| LUMENIS FAMILY OF IPL AND COMBINATION IPL/ND:YAG SYSTEMS (K030527) | Lumenis | 2003-05-20 |
| BCLEAR (K020591) | Lumenis | 2002-05-16 |
| DERMACLEAR UV-B PHOTOTHERAPY SYSTEM (K011197) | Lumenis | 2001-12-14 |
| LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICES (K011703) | Lumenis | 2001-08-29 |