FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HIGH FREQUENCY NEEDLE-TYPE EPILATOR
K Number: K864291
·
Decision Dec 24, 1986
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
42
Applicant Total
1
Review Days
54
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- HIGH FREQUENCY NEEDLE-TYPE EPILATOR
- K Number
- K864291
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.5350
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Multi-Channel Epilator
- Date Received
- October 31, 1986
- Decision Date
- December 24, 1986
- 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 SS-99
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
THE ELITE SPECTRUM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery