FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
Laser Treatment System, Model: Hera, Armo
K Number: K212793
·
Decision Oct 25, 2021
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
3
Review Days
54
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Basic Information
- Device Name
- Laser Treatment System, Model: Hera, Armo
- K Number
- K212793
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Canadian Pioneer Medical Technology Corporation
- Date Received
- September 1, 2021
- Decision Date
- October 25, 2021
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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