COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS
FDA premarket approval P940011 · decided 1995-12-27
Approval details
- PMA number
- P940011
- Trade name
- COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS
- Generic name
- System, laser, photodynamic therapy
- Applicant
- Lumenis, Inc.
- Date received
- 1994-04-13
- Decision date
- 1995-12-27
- Days to decision
- 623 days
- Decision code
- APWD
- Product code
- MVF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Salt Lake City, UT
- Statement
- APPROVAL FOR THE COHERENT PLD1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS
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 |
|---|---|---|
| Lumenis Y&R Laser System (K211979) | Lumenis, Inc. | 2022-06-21 |
| Lumenis Smart532 Laser System (K151109) | Lumenis, Inc. | 2015-10-30 |
| SCANNING LASERLINK (K130195) | Lumenis, Inc. | 2013-11-01 |
| VISION ONE LASER SYSTEM (K111213) | Lumenis, Inc. | 2011-07-25 |
| VERSAPULSE MODEL P20 LASER SYSTEM (K100228) | Lumenis, Inc. | 2010-02-24 |
| POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200 (K091962) | Lumenis, Inc. | 2009-09-30 |
| ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM (K082809) | Lumenis, Inc. | 2008-12-18 |
| SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS (K081704) | Lumenis, Inc. | 2008-09-11 |