FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
JOULE 1064nm System and Accessories
K Number: K251077
·
Decision Dec 19, 2025
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
23
Review Days
255
Basic Information
- Device Name
- JOULE 1064nm System and Accessories
- K Number
- K251077
- 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
- April 8, 2025
- Decision Date
- December 19, 2025
- 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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|---|---|---|---|
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| 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 |