FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRECISE SHP DIODE LASER
K Number: K123443
·
Decision Aug 13, 2013
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
21
Review Days
278
Basic Information
- Device Name
- PRECISE SHP DIODE LASER
- K Number
- K123443
- 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
- CAO GROUP, INC.
- Date Received
- November 8, 2012
- Decision Date
- August 13, 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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|---|---|---|---|
| K150585 | Ascent 3D | Dec 31, 2015 | Substantially Equivalent |
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| K113472 | PRECISE SHP DIODE LASER | Aug 30, 2012 | Substantially Equivalent |
| K103160 | NUPRO MODEL 13016901 | Jan 6, 2011 | Substantially Equivalent |
| K100540 | ASCENT F-COAT MODEL: 006-00097 | Sep 23, 2010 | Substantially Equivalent |
| K100143 | PILOT DIODE LASER, MODEL 002-00139 | Aug 13, 2010 | Substantially Equivalent |
| K092616 | ASCENT BOND UNIVERSAL ADHESIVE SYSTEM, MODELS 006-00029, 006-00030, 006-00044, 006-00045 | Oct 21, 2009 | Substantially Equivalent |
| K091300 | ASCENT PORCELAIN PRIMER, MODEL 006-00078, 00600079 | Jul 23, 2009 | Substantially Equivalent |