FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PALOMAR LUX 1540 HANDPIECE
K Number: K080244
·
Decision Jun 20, 2008
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
21
Review Days
141
Basic Information
- Device Name
- PALOMAR LUX 1540 HANDPIECE
- K Number
- K080244
- 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 PRODUCTS, INC.
- Date Received
- January 31, 2008
- Decision Date
- June 20, 2008
- 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 PRODUCTS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K111840 | EMERGE FRACTIONAL LASER | Nov 14, 2011 | Substantially Equivalent |
| K091446 | MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE | Oct 27, 2009 | Substantially Equivalent |
| K092222 | THERMAPULSE | Aug 20, 2009 | Substantially Equivalent |
| K090525 | LOI SYSTEM | Jun 1, 2009 | Substantially Equivalent |
| K083900 | ERBIUM FRACTIONAL HANDPIECE | Feb 27, 2009 | Substantially Equivalent |
| K083165 | PALOMAR ASPIRE LASER PLATFORM | Feb 13, 2009 | Substantially Equivalent |
| K081416 | PALOMAR ASPIRE LASER PLATFORM | May 29, 2008 | Substantially Equivalent |
| K080567 | PALOMAR ASPIRE LASER PLATFORM | Apr 16, 2008 | Substantially Equivalent |
| K073583 | MODIFICATION TO PALOMAR LUX1540 HANDPIECE | Mar 26, 2008 | Substantially Equivalent |
| K071768 | ERBIUM FRACTIONAL HANDPIECE | Nov 5, 2007 | Substantially Equivalent |