FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRU-PULSE LASER (MODIFIED)
K Number: K963683
·
Decision Feb 12, 1997
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
9
Review Days
167
Basic Information
- Device Name
- TRU-PULSE LASER (MODIFIED)
- K Number
- K963683
- 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
- TISSUE TECHNOLOGIES, INC.
- Date Received
- August 29, 1996
- Decision Date
- February 12, 1997
- 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 TISSUE TECHNOLOGIES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K002071 | SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL MODIFICATIONS FOR STRANDS AND SUTURE HOLES | Jul 24, 2000 | Substantially Equivalent |
| K000849 | SOFTFORM FACIAL IMPLANT | May 19, 2000 | Substantially Equivalent |
| K982475 | SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL | Sep 22, 1998 | Substantially Equivalent |
| K973462 | SOFTFORM FACIAL IMPLANT | Nov 24, 1997 | Substantially Equivalent |
| K970804 | TRU-PULSE CO2 SURGICAL LASER | Jun 3, 1997 | Substantially Equivalent |
| K962496 | SOFT TISSUE AUGMENTATION TUBE (S.T.A.T.) | Sep 3, 1996 | Substantially Equivalent |
| K960481 | SOFT TISSUE AUGMENTATION TUBE | Apr 1, 1996 | Substantially Equivalent |
| K952049 | TRU-PULSE PULSED CO2 SURGICAL LASER SYSTEM | Jul 21, 1995 | Substantially Equivalent |