FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THE SS-99
K Number: K943399
·
Decision Sep 16, 1994
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
42
Applicant Total
7
Review Days
64
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Basic Information
- Device Name
- THE SS-99
- K Number
- K943399
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.5350
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Instantron
- Date Received
- July 14, 1994
- Decision Date
- September 16, 1994
- Product Code
- KCW
- 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 |
|---|---|---|---|
| KCW | Epilator, High Frequency, Needle-Type | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KCW), ordered by most recent decision date.
COMPU-BLEND EPILATOR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATION
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
HAIR REMOVAL SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
APILUS ELECTROPIL
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
THE ELITE SPECTRUM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
THE BLENDTONE ROYALE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Instantron
| K Number | Device Name | ||
|---|---|---|---|
| K943396 | THE ELITE SPECTRUM | Sep 16, 1994 | Substantially Equivalent |
| K943398 | THE BLENDTONE ROYALE | Sep 16, 1994 | Substantially Equivalent |
| K941227 | SHORTWAVE EPILATOR FOR PERMANENT HAIR REMOVAL | Aug 18, 1994 | Substantially Equivalent |
| K931062 | THE VP500 EPILATOR | Jul 8, 1993 | Substantially Equivalent |
| K931063 | THE ELITE EPILATOR | Jul 8, 1993 | Substantially Equivalent |
| K931064 | THE BLENDTONE EPILATOR | Jul 8, 1993 | Substantially Equivalent |