VISION ONE LASER SYSTEM
FDA 510(k) clearance K111213 · decided 2011-07-25
Clearance details
- K-number
- K111213
- Device name
- VISION ONE LASER SYSTEM
- Applicant
- Lumenis, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-05-02
- Decision date
- 2011-07-25
- Days to decision
- 84 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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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use recall (Z-2191-2013) | Lumenis, Inc. | 2013-09-11 |
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 |