510(k) K150323
K150323 is an FDA 510(k) premarket notification submitted by Sie Ag,Surgical Instrument Engineering for the device "FEMTO LDV Z8 Surgical Laser". The FDA issued a decision of Substantially Equivalent on October 23, 2015. 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
- October 23, 2015
- Date Received
- February 9, 2015
- 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.