FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPTIMEDICA CATALYS PRECISION LASER SYSTEM
K Number: K141079
·
Decision Sep 11, 2014
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
46
Applicant Total
8
Review Days
139
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Basic Information
- Device Name
- OPTIMEDICA CATALYS PRECISION LASER SYSTEM
- K Number
- K141079
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4390
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Optimedica Corporation
- Date Received
- April 25, 2014
- Decision Date
- September 11, 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 Optimedica Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K161455 | Catalys Precision Laser System | Sep 20, 2016 | Substantially Equivalent |
| K121091 | CATALYS PRECISION LASER SYSTEM | Aug 28, 2012 | Substantially Equivalent |
| K113479 | OPTIMEDICA CATALYS PRECISION LASER SYSTEM | Dec 21, 2011 | Substantially Equivalent |
| K100019 | PASCAL STREAMLINE PHOTOCOAGULATOR | May 4, 2010 | Substantially Equivalent |
| K091666 | PASCAL PHOTOCOAGULATOR, PASCAL-US | Jul 15, 2009 | Substantially Equivalent |
| K081744 | PASCAL SYNTHESIS DELIVERY SYSTEM | Sep 9, 2008 | Substantially Equivalent |
| K062336 | OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE | Oct 19, 2006 | Substantially Equivalent |