Co2 Laser System, Models: PureLase And VanLase
FDA 510(k) clearance K232133 · decided 2024-04-16
Clearance details
- K-number
- K232133
- Device name
- Co2 Laser System, Models: PureLase And VanLase
- Applicant
- Cpmt Laser (Canadian Pioneer Medical Technology Corporation)
- Decision
- Substantially Equivalent
- Date received
- 2023-07-18
- Decision date
- 2024-04-16
- Days to decision
- 273 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
- Toronto, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.