FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
A.R.C. Laser Surgical Fibers and Probes
K Number: K161403
·
Decision Aug 16, 2016
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
6
Review Days
88
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Basic Information
- Device Name
- A.R.C. Laser Surgical Fibers and Probes
- K Number
- K161403
- 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
- A.R.C Laser GmbH
- Date Received
- May 20, 2016
- Decision Date
- August 16, 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 A.R.C Laser GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K220531 | FOX 810, FOX 980 | Sep 1, 2022 | Substantially Equivalent |
| K192272 | Wolf445nm | Mar 17, 2020 | Substantially Equivalent |
| K170183 | Cetus system, Cetus probe | Sep 27, 2017 | Substantially Equivalent |
| K091059 | FOXQ 980 LASER | Aug 13, 2009 | Substantially Equivalent |
| K073322 | FOX 1-980, FOX Q-1064, FOX-Q-810 | Feb 22, 2008 | Substantially Equivalent |