COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS
FDA premarket approval P940011/S001 · decided 1998-01-09
Approval details
- PMA number
- P940011
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS
- Applicant
- Lumenis, Inc.
- Date received
- 1997-02-14
- Decision date
- 1998-01-09
- Days to decision
- 329 days
- Decision code
- APPR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Salt Lake City, UT
- Statement
- Approval for the additional indication for use for the treatment of microinvasive endobronchial nonsmall cell lung cancer in patients for whom surgery and radiotherapy are not indicated.
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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 |