FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TECHNOMED PULSOLITH 4000 LASER SYSTEM
K Number: K925395
·
Decision May 21, 1993
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
59
Applicant Total
7
Review Days
207
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Basic Information
- Device Name
- TECHNOMED PULSOLITH 4000 LASER SYSTEM
- K Number
- K925395
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Teknomed, Inc.
- Date Received
- October 26, 1992
- Decision Date
- May 21, 1993
- Product Code
- LNK
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LNK | Laser For Gastro-Urology Use | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Teknomed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K920708 | MULTILASE 2500 A | Nov 5, 1992 | Substantially Equivalent |
| K913917 | MULTILASE 2100 C, 2100 D | Nov 5, 1992 | Substantially Equivalent |
| K913290 | MULTILASE 2100 A | Feb 21, 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 |