510(k) K181430
K181430 is an FDA 510(k) premarket notification submitted by Lensar, Inc. for the device "LENSAR Laser System - fs 3D (LLS-fs 3D)". The FDA issued a decision of Substantially Equivalent on August 9, 2018. The device falls under product code OOE (Ophthalmic Femtosecond Laser), a Class II device regulated under 21 CFR 886.4390. Lensar, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 9, 2018
- Date Received
- June 1, 2018
- 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.