FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TXCELL SCANNING LASER DELIVERY SYSTEM
K Number: K121475
·
Decision Nov 28, 2012
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
13
Review Days
194
Basic Information
- Device Name
- TXCELL SCANNING LASER DELIVERY SYSTEM
- K Number
- K121475
- 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
- IRIDEX CORP.
- Date Received
- May 18, 2012
- Decision Date
- November 28, 2012
- 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 IRIDEX CORP.
| K Number | Device Name | ||
|---|---|---|---|
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| K040209 | IRIS MEDICAL IQ 810 PHOTOCOAGULATOR | Sep 20, 2004 | Substantially Equivalent |
| K031665 | IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS | Aug 27, 2003 | Substantially Equivalent |
| K022228 | FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES | Oct 8, 2002 | Substantially Equivalent |
| K020849 | APEX 800 LASER SYSTEM, MODEL APEX 800 | May 20, 2002 | Substantially Equivalent |
| K020374 | OCULIGHT SL/SLX | May 3, 2002 | Substantially Equivalent |