510(k) K212630
K212630 is an FDA 510(k) premarket notification submitted by Ellex Medical Pty, Ltd. for the device "Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo". The FDA issued a decision of Substantially Equivalent on December 16, 2021. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Ellex Medical Pty, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 16, 2021
- Date Received
- August 19, 2021
- 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