FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DORNIER MEDILAS D LITEBEAM+ 1470
K Number: K110364
·
Decision Dec 7, 2011
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
29
Review Days
303
Basic Information
- Device Name
- DORNIER MEDILAS D LITEBEAM+ 1470
- K Number
- K110364
- 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
- DORNIER MEDTECH AMERICA, INC.
- Date Received
- February 7, 2011
- Decision Date
- December 7, 2011
- 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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|---|---|---|---|
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| K123385 | MEDILAS H LASER FIBERS | Dec 14, 2012 | Substantially Equivalent |
| K121656 | GEMINI LITHOTRIPTER | Sep 24, 2012 | Substantially Equivalent |
| K121938 | MEDILAS H RFID LASER FIBER | Aug 1, 2012 | Substantially Equivalent |
| K083500 | MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE | Feb 12, 2009 | Substantially Equivalent |