VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETER SYSTEM
FDA 510(k) clearance K053087 · decided 2006-03-01
Clearance details
- K-number
- K053087
- Device name
- VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETER SYSTEM
- Applicant
- Biotex, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-11-02
- Decision date
- 2006-03-01
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Houston, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. recall (Z-0244-2023) | Medtronic Navigation, Inc. | 2022-11-17 |
| Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9735561, (1) L recall (Z-2755-2017) | Medtronic Navigation, Inc. | 2017-07-03 |
| Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visuala recall (Z-1672-2016) | Medtronic Navigation, Inc. | 2016-05-16 |