510(k) K163551
K163551 is an FDA 510(k) premarket notification submitted by Alcon Laboratories, Inc. for the device "LenSx Laser System". The FDA issued a decision of Substantially Equivalent on Feb 3, 2017. The device falls under product code OOE (Ophthalmic Femtosecond Laser), a Class II device regulated under 21 CFR 886.4390. Alcon Laboratories, Inc. has 89 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 3, 2017
- Date Received
- Dec 19, 2016
- 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
- 510(k)
Precise cutting or ablation of ocular tissue, indicated for the anterior capsulotomy during cataract surgery.