FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLARITY LPC LASER SYSTEM
K Number: K130199
·
Decision Nov 22, 2013
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
19
Review Days
298
Basic Information
- Device Name
- CLARITY LPC LASER SYSTEM
- K Number
- K130199
- 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
- LUTRONIC CORPORATION
- Date Received
- January 28, 2013
- Decision Date
- November 22, 2013
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEX), ordered by most recent decision date.
AviClear Laser System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Pastelle
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SurgiLight 1470 Diode Laser System (Model:Halo)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AuroLase® System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Diode laser device (RF3120-BI)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by LUTRONIC CORPORATION
| K Number | Device Name | ||
|---|---|---|---|
| K163196 | ACTION II Laser System | May 24, 2017 | Substantially Equivalent |
| K141555 | ADVANTAGE | Nov 6, 2014 | Substantially Equivalent |
| K121481 | INFINI RADIOFREQUENCY SYSTEM | Jun 25, 2013 | Substantially Equivalent |
| K113843 | FREEDOM ND: YAG LASER SYSTEM | Sep 27, 2012 | Substantially Equivalent |
| K113668 | HEALITE II SYSTEM | Jun 19, 2012 | Substantially Equivalent |
| K113502 | ADVANTAGE LASER SYSTEM | Apr 5, 2012 | Substantially Equivalent |
| K113588 | SPECTRA LASER SYSTEM | Feb 22, 2012 | Substantially Equivalent |
| K103455 | SPECTRA LASER SYSTEM | Apr 28, 2011 | Substantially Equivalent |
| K100610 | LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMS | Jan 20, 2011 | Substantially Equivalent |
| K101573 | ACCUSCULPT II LASER SYSTEM | Sep 23, 2010 | Substantially Equivalent |