FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NEMDI
K Number: K843734
·
Decision Oct 25, 1984
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
24
Applicant Total
13
Review Days
31
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Basic Information
- Device Name
- NEMDI
- K Number
- K843734
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.5360
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Nemectron Medical, Inc.
- Date Received
- September 24, 1984
- Decision Date
- October 25, 1984
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KCX), ordered by most recent decision date.
DAPELLE HAIR REMOVER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TWEEZER-TYPE EPILATOR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
FEMINIQUE SONIC HAIR REMOVER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SONIQUE HAIR REMOVER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
FINALLY FREE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TWEEZER-TYPE EPILATOR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Nemectron Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K923396 | THERMODYN | May 26, 1993 | Substantially Equivalent |
| K895000 | NEMECTRON MICROWAVE | Jul 27, 1990 | Substantially Equivalent |
| K862376 | NEMECTROSON MODEL 2 | Jul 23, 1986 | Substantially Equivalent |
| K854720 | NEMECTRODYN MODEL 2 & ENDOVAC 2 POWER MUSCLE STIM. | Mar 10, 1986 | Substantially Equivalent |
| K854721 | NEMECTRODYN MODEL 2 & ENDOVAC 2 | Mar 6, 1986 | Substantially Equivalent |
| K844416 | THERMOPULS E | Mar 12, 1985 | Substantially Equivalent |
| K843735 | SOFTEPIL | Oct 25, 1984 | Substantially Equivalent |
| K823511 | EMG BIOFEEDBACK DEVICE | Mar 31, 1983 | Substantially Equivalent |
| K820334 | NEMECTRODYN MODELS 8,7,5 (VOLS. I-IV | Mar 15, 1982 | Substantially Equivalent |
| K810513 | ELECTRODYN CII-INTERFERENTIAL MUSCLE | May 11, 1981 | Substantially Equivalent |