FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
INTRAGen
K Number: K142833
·
Decision Jun 4, 2015
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
4
Applicant Total
15
Review Days
247
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Basic Information
- Device Name
- INTRAGen
- K Number
- K142833
- 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
- September 30, 2014
- Decision Date
- June 4, 2015
- Product Code
- OUH
- 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 |
|---|---|---|---|
| OUH | Skin Resurfacing Rf Applicator | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OUH), ordered by most recent decision date.
VIVACE Electrosurgical System
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FDA Class 2
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INTENSIF
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FDA Class 2
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GLOW BY ENDYMED
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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