FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROFILE 1320 LASER SYSTEM
K Number: K022466
·
Decision Dec 31, 2002
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
16
Review Days
159
Basic Information
- Device Name
- PROFILE 1320 LASER SYSTEM
- K Number
- K022466
- 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
- SCITON, INC.
- Date Received
- July 25, 2002
- Decision Date
- December 31, 2002
- 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 SCITON, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K122567 | JOULE 810/940/980 MULTI-PLATFORM SYSTEM | Jun 19, 2013 | Substantially Equivalent |
| K111483 | JOULE CLEARSENSE LASER SYSTEM | Dec 7, 2011 | Substantially Equivalent |
| K101916 | JOULE MULTI-PLATFORM SYSTEM | Mar 18, 2011 | Substantially Equivalent |
| K081352 | PROFILE MULTI-PLATFORM SYSTEM | Oct 23, 2008 | Substantially Equivalent |
| K070388 | PROFILE MULTI-PLATFORM SYSTEM | May 2, 2007 | Substantially Equivalent |
| K060033 | PROFILE MULTI-PLATFORM SYSTEM | Feb 28, 2006 | Substantially Equivalent |
| K040005 | PROFILE 2000/3000 LASER SYSTEM | Mar 29, 2004 | Substantially Equivalent |
| K032459 | PROFILE 1320 LASER SYSTEM | Mar 9, 2004 | Substantially Equivalent |
| K032460 | PROFILE BBL SYSTEM | Nov 13, 2003 | Substantially Equivalent |
| K023881 | PROFILE 1064 LASER SYSTEM | Jun 13, 2003 | Substantially Equivalent |