510(k) K091064
K091064 is an FDA 510(k) premarket notification submitted by Od-Os GmbH for the device "NAVILAS LASER SYSTEM". The FDA issued a decision of Substantially Equivalent on October 27, 2009. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Od-Os GmbH has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 27, 2009
- Date Received
- April 14, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laser, Ophthalmic
- Device Class
- Class II
- Regulation Number
- 886.4390
- Review Panel
- OP
- Submission Type