FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPHINX JR
K Number: K132975
·
Decision Mar 18, 2014
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
8
Review Days
176
Basic Information
- Device Name
- SPHINX JR
- K Number
- K132975
- 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
- ALLMED SYSTEMS INC.
- Date Received
- September 23, 2013
- Decision Date
- March 18, 2014
- 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 ALLMED SYSTEMS INC.
| K Number | Device Name | ||
|---|---|---|---|
| K110941 | REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200 | Feb 19, 2013 | Substantially Equivalent |
| K070924 | FLEXGUARD | Jun 21, 2007 | Substantially Equivalent |
| K070466 | REVOLIX DUO LASER SYSTEM | Apr 17, 2007 | Substantially Equivalent |
| K070476 | REVOLIX 120 | Mar 26, 2007 | Substantially Equivalent |
| K051167 | REVOLIX AND REVOLIX JR | Jun 1, 2005 | Substantially Equivalent |
| K033437 | SPHINX LASER SYSTEMS | Jan 20, 2004 | Substantially Equivalent |
| K033423 | REVOLIX LASER SYSTEMS | Jan 15, 2004 | Substantially Equivalent |