FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
INTRAcel Premium Fractional RF Micro Needle (FRM) System
K Number: K153727
·
Decision Jul 21, 2016
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
15
Review Days
206
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Basic Information
- Device Name
- INTRAcel Premium Fractional RF Micro Needle (FRM) System
- K Number
- K153727
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Jeisys Medical, Inc.
- Date Received
- December 28, 2015
- Decision Date
- July 21, 2016
- Product Code
- GEI
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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