FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICES
K Number: K011703
·
Decision Aug 29, 2001
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
5
Review Days
89
Basic Information
- Device Name
- LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICES
- K Number
- K011703
- 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
- LUMENIS
- Date Received
- June 1, 2001
- Decision Date
- August 29, 2001
- 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 LUMENIS
| K Number | Device Name | ||
|---|---|---|---|
| K100415 | ACUPULSE 30/40 ST CO2 LASER SYSTEM AND ACUPULSE 40WG CO2 LASER SYSTEM | Apr 21, 2010 | Substantially Equivalent |
| K030527 | LUMENIS FAMILY OF IPL AND COMBINATION IPL/ND:YAG SYSTEMS | May 20, 2003 | Substantially Equivalent |
| K020591 | BCLEAR | May 16, 2002 | Substantially Equivalent |
| K011197 | DERMACLEAR UV-B PHOTOTHERAPY SYSTEM | Dec 14, 2001 | Substantially Equivalent |