FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Gemini 2 810+980 Soft Tissue Laser
K Number: K210350
·
Decision Nov 18, 2021
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
16
Applicant Total
4
Review Days
283
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Basic Information
- Device Name
- Gemini 2 810+980 Soft Tissue Laser
- K Number
- K210350
- 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
- Azena Medical, LLC
- Date Received
- February 8, 2021
- Decision Date
- November 18, 2021
- Product Code
- NVK
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| NVK | Laser, Dental, Soft Tissue | FDA class 2 | General, Plastic Surgery |
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