FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Sterling 5W Diode Laser
K Number: K160413
·
Decision Sep 21, 2016
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
9
Review Days
218
Basic Information
- Device Name
- Sterling 5W Diode Laser
- K Number
- K160413
- 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
- February 16, 2016
- Decision Date
- September 21, 2016
- 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 CAO Group, Inc.
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|---|---|---|---|
| K201904 | Monet Curing Laser | Nov 24, 2020 | Substantially Equivalent |
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| K181601 | Precise SHP Diode Laser | Sep 9, 2019 | Substantially Equivalent |
| K171052 | Ultimate Contour, Ultimate Contour Mini | Oct 20, 2017 | Substantially Equivalent |
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| K142225 | Pilot Elite Diode Laser | Sep 12, 2014 | Substantially Equivalent |