FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
ACUPULSE 30/40 ST CO2 LASER SYSTEM AND ACUPULSE 40WG CO2 LASER SYSTEM
K Number: K100415
·
Decision Apr 21, 2010
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
5
Review Days
64
Basic Information
- Device Name
- ACUPULSE 30/40 ST CO2 LASER SYSTEM AND ACUPULSE 40WG CO2 LASER SYSTEM
- K Number
- K100415
- 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
- February 16, 2010
- Decision Date
- April 21, 2010
- 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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Other Clearances by LUMENIS
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K011703 | LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICES | Aug 29, 2001 | Substantially Equivalent |