FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNICA 315 M CO2 SURGICAL LASER SYSTEM
K Number: K971821
·
Decision Sep 25, 1997
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
19
Review Days
132
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Basic Information
- Device Name
- UNICA 315 M CO2 SURGICAL LASER SYSTEM
- K Number
- K971821
- 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
- Reliant Technologies, Inc.
- Date Received
- May 16, 1997
- Decision Date
- September 25, 1997
- 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 Reliant Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K080915 | FRAXEL RE:PAIR (FRAXEL III SR) LASER SYSTEM AND ACCESSORIES | Jul 1, 2008 | Substantially Equivalent |
| K071051 | FRAXEL III SR LASER SYSTEM AND ACCESSORIES | Nov 2, 2007 | Substantially Equivalent |
| K071621 | RELIANT TECHNOLOGIES C300 CHILLER SYSTEM AND ACCESSORIES | Oct 9, 2007 | Substantially Equivalent |
| K070284 | FRALEX SR 1500 LASER SYSTEM (FRALEX II SR LASER SYSTEM) | May 17, 2007 | Substantially Equivalent |
| K063808 | FRAXEL IV SR LASER SYSTEM | Apr 27, 2007 | Substantially Equivalent |
| K063038 | FRAXEL III SR LASER SYSTEM AND ACCESSORIES | Apr 27, 2007 | Substantially Equivalent |
| K062303 | FRAXEL II SR LASER SYSTEM | Jan 31, 2007 | Substantially Equivalent |
| K060310 | FRAXEL II SR LASER SYSTEM AND ACCESSORIES | Mar 29, 2006 | Substantially Equivalent |
| K053047 | FRAXEL SR LASER SYSTEM | Mar 20, 2006 | Substantially Equivalent |
| K050841 | FRAXEL SR LASER SYSTEM | Jul 5, 2005 | Substantially Equivalent |