SCANNING LASERLINK
FDA 510(k) clearance K130195 · decided 2013-11-01
Clearance details
- K-number
- K130195
- Device name
- SCANNING LASERLINK
- Applicant
- Lumenis, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-01-28
- Decision date
- 2013-11-01
- Days to decision
- 277 days
- Clearance type
- Abbreviated
- Product code
- HQF
- Device class
- 2
- Regulation number
- 886.4390
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system accessor recall (Z-2733-2014) | Lumenis, Inc. | 2014-09-30 |
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 |