510(k) K190083
K190083 is an FDA 510(k) premarket notification submitted by Norlase Aps for the device "Leaf Photocoagulator". The FDA issued a decision of Substantially Equivalent on May 3, 2019. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Norlase Aps has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 3, 2019
- Date Received
- January 17, 2019
- 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