VERSAPULSE MODEL P20 LASER SYSTEM
FDA 510(k) clearance K100228 · decided 2010-02-24
Clearance details
- K-number
- K100228
- Device name
- VERSAPULSE MODEL P20 LASER SYSTEM
- Applicant
- Lumenis, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-01-26
- Decision date
- 2010-02-24
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS (P940011/S002) | Lumenis, Inc. | 1998-12-23 |
| COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS (P940011/S003) | Lumenis, Inc. | 1998-11-24 |
| COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS (P940011/S001) | Lumenis, Inc. | 1998-01-09 |
| COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS (P940011) | Lumenis, Inc. | 1995-12-27 |