510(k) K202760
K202760 is an FDA 510(k) premarket notification submitted by Iridex Corporation for the device "Iridex 810 Laser". The FDA issued a decision of Substantially Equivalent on Oct 21, 2020. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Iridex Corporation has 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 21, 2020
- Date Received
- Sep 21, 2020
- Clearance Type
- Special
- 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)