Laser Treatment System, Model: Hera, Armo
FDA 510(k) clearance K212793 · decided 2021-10-25
Clearance details
- K-number
- K212793
- Device name
- Laser Treatment System, Model: Hera, Armo
- Applicant
- Canadian Pioneer Medical Technology Corporation
- Decision
- Substantially Equivalent
- Date received
- 2021-09-01
- Decision date
- 2021-10-25
- Days to decision
- 54 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
- Vaughan, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.