FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QYAG LASER SYSTEM
K Number: K130250
·
Decision May 3, 2013
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
24
Review Days
91
Basic Information
- Device Name
- QYAG LASER SYSTEM
- K Number
- K130250
- 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
- PALOMAR MEDICAL TECHNOLOGIES, INC.
- Date Received
- February 1, 2013
- Decision Date
- May 3, 2013
- 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 PALOMAR MEDICAL TECHNOLOGIES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K120622 | PALOMAR VECTUS LASER | May 23, 2012 | Substantially Equivalent |
| K110907 | PALOMAR ICON (TM) AESTHETIC SYSTEM | Jun 22, 2011 | Substantially Equivalent |
| K103664 | PRIMUS AESTHETIC PLATFORM | Mar 17, 2011 | Substantially Equivalent |
| K101506 | LUX1540, LUX1440 & LUX2940 LASER HANDPIECES | Sep 1, 2010 | Substantially Equivalent |
| K100270 | ARTISAN AESTHETIC SYSTEM | Mar 29, 2010 | Substantially Equivalent |
| K090195 | PALOMAR LUX1540 HANDPIECE | Nov 20, 2009 | Substantially Equivalent |
| K070298 | MODIFICATION TO PALOMAR LUXIR HANDPIECE | Jul 3, 2007 | Substantially Equivalent |
| K063571 | PALOMAR LUX2940 HANDPIECE | Feb 9, 2007 | Substantially Equivalent |
| K060839 | ABC HAIR REMOVAL SYSTEM | Dec 7, 2006 | Substantially Equivalent |
| K061436 | PALOMAR Q-YAG 5 ND:YAG LASER SYSTEM | Dec 6, 2006 | Substantially Equivalent |