510(k) K990075
K990075 is an FDA 510(k) premarket notification submitted by Light-Med(Usa), Inc. for the device "LPULSA SYL-9000 OPHTHALMIC YAG LASER". The FDA issued a decision of Substantially Equivalent on Mar 30, 1999. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Light-Med(Usa), Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 30, 1999
- Date Received
- Jan 11, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laser, Ophthalmic
- Device Class
- Class II
- Regulation Number
- 886.4390
- Review Panel
- OP
- Submission Type
- 510(k)