FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SONIQUE HAIR REMOVER
K Number: K973174
·
Decision Oct 30, 1997
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
24
Applicant Total
3
Review Days
66
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Basic Information
- Device Name
- SONIQUE HAIR REMOVER
- K Number
- K973174
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.5360
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Global TV Concepts, Ltd.
- Date Received
- August 25, 1997
- Decision Date
- October 30, 1997
- Product Code
- KCX
- 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 |
|---|---|---|---|
| KCX | Epilator, High Frequency, Tweezer-Type | FDA class 1 | General, Plastic Surgery |
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