FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DERMOLAS
K Number: K832983
·
Decision Apr 23, 1984
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
4
Review Days
234
Basic Information
- Device Name
- DERMOLAS
- K Number
- K832983
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- MEDITEC, INC.
- Date Received
- September 2, 1983
- Decision Date
- April 23, 1984
- Product Code
- GEX
- 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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Other Clearances by MEDITEC, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K854833 | MDS-83 IN DERMATOLOGICAL/PLASTIC SURGERY APPLICATI | Apr 4, 1986 | Substantially Equivalent |
| K852234 | MDS 83 OPHTHALMIC DYE LASER SYSTEM | Aug 1, 1985 | Substantially Equivalent |
| K837030 | MODEL ML-4000 OPHTHALMIC LASER WITH FIBER OPTIC DELIVERY SYSTEM | Jan 24, 1983 | Substantially Equivalent |