FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CO2 LASER COUPLER
K Number: K983965
·
Decision Dec 22, 1998
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
13
Review Days
46
Basic Information
- Device Name
- CO2 LASER COUPLER
- K Number
- K983965
- 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
- LASER, INC.
- Date Received
- November 6, 1998
- Decision Date
- December 22, 1998
- 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 LASER, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K950021 | REUSABLE TROCAR WITH SAFETY SLEEVE | Mar 31, 1995 | Substantially Equivalent |
| K940454 | GRASPING FORCEPS, PUNCHES, SCISSORS | Mar 25, 1994 | Substantially Equivalent |
| K931561 | TROCAR SLEEVE | Feb 7, 1994 | Substantially Equivalent |
| K933421 | ENDOSCOPIC INSTRUMENTS AND ACCESSDORIES | Nov 2, 1993 | Substantially Equivalent |
| K924844 | BULK TISSUE REMOVAL SYSTEM | Oct 8, 1993 | Substantially Equivalent |
| K932045 | DISPOSABLE INSUFFLATION TUBING | Sep 23, 1993 | Substantially Equivalent |
| K931092 | ENDOSCOPIC RETRACTOR | Apr 30, 1993 | Substantially Equivalent |
| K914197 | ALLOY SCALPEL HANDPIECES | Apr 10, 1992 | Substantially Equivalent |
| K904638 | TROCAR DISPOSABLE | Feb 21, 1991 | Substantially Equivalent |
| K892912 | MODEL JM-1 CO2 LASER | Mar 6, 1990 | Substantially Equivalent |