510(k) K233911
K233911 is an FDA 510(k) premarket notification submitted by Carl Zeiss Meditec, AG for the device "VISULAS combi". The FDA issued a decision of Substantially Equivalent on September 6, 2024. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Carl Zeiss Meditec, AG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 6, 2024
- Date Received
- December 12, 2023
- 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