FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
QUANTA DIODE LASER SYSTEM
K Number: K100558
·
Decision Jul 22, 2010
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
15
Review Days
143
Basic Information
- Device Name
- QUANTA DIODE LASER SYSTEM
- K Number
- K100558
- 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
- QUANTA SYSTEM, S.P.A.
- Date Received
- March 1, 2010
- Decision Date
- July 22, 2010
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- Y
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 QUANTA SYSTEM, S.P.A.
| K Number | Device Name | ||
|---|---|---|---|
| K141101 | LITHO | Aug 8, 2014 | Substantially Equivalent |
| K141403 | LITHO DK30 | Aug 7, 2014 | Substantially Equivalent |
| K131473 | (QUANTA SYSTEM) SURGICAL LASER FIBERS | Oct 24, 2013 | Substantially Equivalent |
| K123573 | YOULASER CO2 LASER | Apr 15, 2013 | Substantially Equivalent |
| K111592 | YOULASER CO2 LASER SYSTEM | Aug 25, 2011 | Substantially Equivalent |
| K103539 | QUANTA SYSTEM DUOLITE | Jan 20, 2011 | Substantially Equivalent |
| K091909 | LITHO LASER SYSTEM | Jul 9, 2009 | Substantially Equivalent |
| K090962 | CYBER SURGICAL LASER FAMILY INCLUDING: CYBER TM, CYBER GREEN, CYBER GREEN TM | Jun 19, 2009 | Substantially Equivalent |
| K083613 | QUANTA SYSTEM POLYSURGE DIODE LASER FAMILY | Dec 23, 2008 | Substantially Equivalent |
| K083207 | ULTRAWAVE III EX 1320 | Nov 14, 2008 | Substantially Equivalent |