FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LUMENIS ONE FAMILY OF SYSTEMS; LUMENIS ONE.
K Number: K060448
·
Decision Jul 6, 2006
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
6
Review Days
135
Basic Information
- Device Name
- LUMENIS ONE FAMILY OF SYSTEMS; LUMENIS ONE.
- K Number
- K060448
- 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 LTD.
- Date Received
- February 21, 2006
- Decision Date
- July 6, 2006
- 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 LTD.
| K Number | Device Name | ||
|---|---|---|---|
| K133272 | VERSACUT + TISSUE MORCELLATOR | May 13, 2014 | Substantially Equivalent |
| K133319 | ET LIGHTSHEER 1060, HIGH SPEED LIGHTSHEER 1060 | Mar 20, 2014 | Substantially Equivalent |
| K140388 | LUMENIS PULSE 120H | Mar 14, 2014 | Substantially Equivalent |
| K130164 | FIBERLASE ENDURE CO2 FIBER | Mar 24, 2013 | Substantially Equivalent |
| K040270 | OPUSDUO; OPUSDUO E; OPUSDUO EC; OPUS 20; OPUS SPECTRUM | Dec 16, 2004 | Substantially Equivalent |