BCLEAR
FDA 510(k) clearance K021762 · decided 2002-08-23
Clearance details
- K-number
- K021762
- Device name
- BCLEAR
- Applicant
- Lumenis, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-05-29
- Decision date
- 2002-08-23
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- FTC
- Device class
- 2
- Regulation number
- 878.4630
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Pleasanton, CA, 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 |