FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURELASE CO2 LASER SYSTEM
K Number: K121580
·
Decision Sep 25, 2012
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
9
Review Days
118
Basic Information
- Device Name
- SURELASE CO2 LASER SYSTEM
- K Number
- K121580
- 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
- CLINICON CORP.
- Date Received
- May 30, 2012
- Decision Date
- September 25, 2012
- 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 CLINICON CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K063698 | CO2 LASER SYSTEM, MODEL C-LAS | Mar 2, 2007 | Substantially Equivalent |
| K014236 | CLINICON WAVEGUIDE PLATFORM WITH INTERCONNECT FOR LUXAR ACCESSORIES | Mar 26, 2002 | Substantially Equivalent |
| K014048 | CLINICON UNIVERSAL WAVEGUIDE HANDPIECE AND FIBER TIPS | Feb 11, 2002 | Substantially Equivalent |
| K992472 | SUREGUIDE CO2 LASER BEAM DELIVERY SYSTEM | Sep 8, 1999 | Substantially Equivalent |
| K983463 | SURECAUT DIAMOND LASER KNIFE | Dec 11, 1998 | Substantially Equivalent |
| K970143 | C4 | Oct 29, 1997 | Substantially Equivalent |
| K964831 | SURESCAN | Aug 8, 1997 | Substantially Equivalent |
| K962242 | SURESCAN | Sep 3, 1996 | Substantially Equivalent |