FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDIDIODE
K Number: K231950
·
Decision Aug 9, 2024
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
3
Review Days
406
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Basic Information
- Device Name
- MEDIDIODE
- K Number
- K231950
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medicreations, LLC
- Date Received
- June 30, 2023
- Decision Date
- August 9, 2024
- 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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