FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VICTUS FEMTOSECOND LASER PLATFORM
K Number: K132534
·
Decision Feb 14, 2014
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
46
Applicant Total
10
Review Days
185
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Basic Information
- Device Name
- VICTUS FEMTOSECOND LASER PLATFORM
- K Number
- K132534
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4390
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Technolas Perfect Vision GmbH
- Date Received
- August 13, 2013
- Decision Date
- February 14, 2014
- Product Code
- OOE
- 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 |
|---|---|---|---|
| OOE | Ophthalmic Femtosecond Laser | FDA class 2 | Ophthalmic |
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Other Clearances by Technolas Perfect Vision GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K200724 | VICTUS Femtosecond Laser Platform | Sep 1, 2020 | Substantially Equivalent |
| K171014 | VICTUS Femtosecond Laser Platform | Oct 19, 2017 | Substantially Equivalent |
| K151161 | VICTUS Femtosecond Laser Platform | Jun 24, 2015 | Substantially Equivalent |
| K141379 | VICTUS FEMTOSECOND LASER PLATFORM | Jan 16, 2015 | Substantially Equivalent |
| K140615 | VICTUS FEMTOSECOND LASER PLATFORM | Jul 15, 2014 | Substantially Equivalent |
| K122386 | VICTUS FEMTOSECOND LASER PLATFORM | Feb 8, 2013 | Substantially Equivalent |
| K120426 | VICTUS LASER PLATFORM | Jul 31, 2012 | Substantially Equivalent |
| K110427 | FEMTEC LASER SYSTEM FOR CAPSULOTOMY | Nov 22, 2011 | Substantially Equivalent |
| K984443 | ORBSCAN | Mar 5, 1999 | Substantially Equivalent |