FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
JOULE CLEARSENSE LASER SYSTEM
K Number: K111483
·
Decision Dec 7, 2011
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
18
Applicant Total
23
Review Days
190
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Basic Information
- Device Name
- JOULE CLEARSENSE LASER SYSTEM
- K Number
- K111483
- 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
- May 31, 2011
- Decision Date
- December 7, 2011
- Product Code
- PDZ
- 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 |
|---|---|---|---|
| PDZ | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Sciton, Inc
| K Number | Device Name | ||
|---|---|---|---|
| K251077 | JOULE 1064nm System and Accessories | Dec 19, 2025 | Substantially Equivalent |
| K222958 | mJOULE RF System and Accessories | Apr 23, 2024 | Substantially Equivalent |
| K213761 | Joule diVa System | Jul 19, 2022 | Substantially Equivalent |
| K213350 | mJOULE System and Accessories | Apr 15, 2022 | Substantially Equivalent |
| K182173 | Joule System | Mar 6, 2019 | Substantially Equivalent |
| K180508 | JOULE SYSTEM | May 18, 2018 | Substantially Equivalent |
| K173285 | JOULE SYSTEM | Jan 29, 2018 | Substantially Equivalent |
| K122567 | JOULE 810/940/980 MULTI-PLATFORM SYSTEM | Jun 19, 2013 | Substantially Equivalent |
| K101916 | JOULE MULTI-PLATFORM SYSTEM | Mar 18, 2011 | Substantially Equivalent |
| K081352 | PROFILE MULTI-PLATFORM SYSTEM | Oct 23, 2008 | Substantially Equivalent |