510(k) K210701
K210701 is an FDA 510(k) premarket notification submitted by Amo Manufacturing USA, LLC for the device "CATALYS Precision Laser System". The FDA issued a decision of Substantially Equivalent on April 7, 2021. The device falls under product code OOE (Ophthalmic Femtosecond Laser), a Class II device regulated under 21 CFR 886.4390. Amo Manufacturing USA, LLC has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 7, 2021
- Date Received
- March 9, 2021
- Clearance Type
- Special
- 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.