510(k) K213559
K213559 is an FDA 510(k) premarket notification submitted by Sie Ag,Surgical Instrument Engineering for the device "FEMTO LDV Z8 Femtosecond Surgical Laser". The FDA issued a decision of Substantially Equivalent on April 21, 2022. The device falls under product code OOE (Ophthalmic Femtosecond Laser), a Class II device regulated under 21 CFR 886.4390. Sie Ag,Surgical Instrument Engineering has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 21, 2022
- Date Received
- November 4, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ophthalmic Femtosecond Laser
- Device Class
- Class II
- Regulation Number
- 886.4390
- Review Panel
- OP
- Submission Type
Precise cutting or ablation of ocular tissue, indicated for the anterior capsulotomy during cataract surgery.