COHERENT OPAL PHOTOACTIVATOR
FDA premarket approval P990049/S001 · decided 2001-09-27
Approval details
- PMA number
- P990049
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- COHERENT OPAL PHOTOACTIVATOR
- Generic name
- System, laser, photodynamic therapy
- Applicant
- Lumenis
- Date received
- 2000-08-16
- Decision date
- 2001-09-27
- Days to decision
- 407 days
- Decision code
- APPR
- Product code
- MVF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Salt Lake City, UT
- Statement
- APPROVAL FOR A REVISION OF THE INDICATION FOR USE STATEMENT TO READ "FOR THE TREATMENT OF PATIENTS WITH PREDOMINANTLY CLASSIC SUBFOVEAL CHOROIDAL NEOVASCULARIZATION DUE TO AGE-RELATED MACULAR DEGENERATION, PATHOLOGIC MYOPIA OR PRESUMED OCULAR HISTOPLASMOSIS."
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |