FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MULTILASE 2100 A
K Number: K913290
·
Decision Feb 21, 1992
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
7
Review Days
212
Basic Information
- Device Name
- MULTILASE 2100 A
- K Number
- K913290
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- TEKNOMED, INC.
- Date Received
- July 24, 1991
- Decision Date
- February 21, 1992
- 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 TEKNOMED, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K925395 | TECHNOMED PULSOLITH 4000 LASER SYSTEM | May 21, 1993 | Substantially Equivalent |
| K913917 | MULTILASE 2100 C, 2100 D | Nov 5, 1992 | Substantially Equivalent |
| K920708 | MULTILASE 2500 A | Nov 5, 1992 | Substantially Equivalent |
| K895178 | TECHNOMED PULSOLITH LASER SYSTEM | Oct 6, 1989 | Substantially Equivalent |
| K890436 | TECHNOMED PULSOLITH LASER SYSTEM | Mar 23, 1989 | Substantially Equivalent |
| K790132 | TECNOTOMO | Feb 21, 1979 | Substantially Equivalent |