FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VIRIDIS DERMA LASER
K Number: K020071
·
Decision Apr 5, 2002
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
21
Review Days
86
Basic Information
- Device Name
- VIRIDIS DERMA LASER
- K Number
- K020071
- 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
- QUANTEL MEDICAL
- Date Received
- January 9, 2002
- Decision Date
- April 5, 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 |
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 QUANTEL MEDICAL
| K Number | Device Name | ||
|---|---|---|---|
| K140336 | OPTIMUS FUSION: SLT, YAG AND YAG/SLT | Jun 25, 2014 | Substantially Equivalent |
| K130933 | SOLUTIS | Aug 2, 2013 | Substantially Equivalent |
| K122251 | VITRA MULTISPOT | Jan 24, 2013 | Substantially Equivalent |
| K120825 | SUPRA SCAN DELIVERY SYSTEM | Sep 14, 2012 | Substantially Equivalent |
| K100678 | SUPRA SCAN DELIVERY SYSTEM | Jul 21, 2010 | Substantially Equivalent |
| K091581 | SUPRA 577.Y LASER | Jun 16, 2009 | Substantially Equivalent |
| K081946 | SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR | Mar 25, 2009 | Substantially Equivalent |
| K070776 | SUPRA OPHTHALMIC LASER PHOTOCOAGULATOR | Apr 24, 2007 | Substantially Equivalent |
| K051851 | AVISO OPHTHALMIC ULTRASOUND SYSTEM | Aug 3, 2005 | Substantially Equivalent |
| K043613 | Q-SWITCHED ND:YAG OPHTALMIC LASER (WITH SLIT LAMP), MODEL OPTIMIS II | Mar 24, 2005 | Substantially Equivalent |