510(k) K222655
K222655 is an FDA 510(k) premarket notification submitted by Photonicare, Inc. for the device "OtoSight Middle Ear Scope". The FDA issued a decision of Substantially Equivalent on Sep 26, 2022. The device falls under product code QJG (Device System, Imaging, Tympanic Membrane And Middle Ear), a Class II device regulated under 21 CFR 892.1560. Photonicare, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 26, 2022
- Date Received
- Sep 2, 2022
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device System, Imaging, Tympanic Membrane And Middle Ear
- Device Class
- Class II
- Regulation Number
- 892.1560
- Review Panel
- EN
- Submission Type
- 510(k)
Is intended for use as an imaging tool for visualization of the human tympanic membrane and middle ear space.