FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IRIDEX WIRELESS FOOTSWITCH
K Number: K062074
·
Decision Nov 14, 2006
Classifications
1
FEI Numbers
60
Registration Numbers
61
Same Product Code
179
Applicant Total
13
Review Days
116
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- IRIDEX WIRELESS FOOTSWITCH
- K Number
- K062074
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4390
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Iridex Corp
- Date Received
- July 21, 2006
- Decision Date
- November 14, 2006
- Product Code
- HQF
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HQF | Laser, Ophthalmic | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HQF), ordered by most recent decision date.
Voyager DSLT (430840610)
FDA 510(k)
FDA Class 2
·Ophthalmic
INTEGRE LIO
FDA 510(k)
FDA Class 2
·Ophthalmic
Navilas Laser System 577sl (156691)
FDA 510(k)
FDA Class 2
·Ophthalmic
EyeQ nanoECP
FDA 510(k)
FDA Class 2
·Ophthalmic
Leos Laser and Endoscopy System
FDA 510(k)
FDA Class 2
·Ophthalmic
LYNX Photocoagulator
FDA 510(k)
FDA Class 2
·Ophthalmic
Other Clearances by Iridex Corp
| K Number | Device Name | ||
|---|---|---|---|
| K121475 | TXCELL SCANNING LASER DELIVERY SYSTEM | Nov 28, 2012 | Substantially Equivalent |
| K071687 | FAMILI OF IRIDEX IQ LASER SYSTEMS | Aug 7, 2008 | Substantially Equivalent |
| K062369 | IRIDEX OCULIGHT TX | Nov 8, 2006 | Substantially Equivalent |
| K060905 | IRIDEX OTOPROBE LONG AND SHORT ANGLES, P/N 14310-1 AND 14320-1 | May 31, 2006 | Substantially Equivalent |
| K050562 | OCULIGHT GL/GLX | Apr 14, 2005 | Substantially Equivalent |
| 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 |