510(k) K222492
K222492 is an FDA 510(k) premarket notification submitted by Lujena, Inc. for the device "Hope&Her Vaginal Dilators". The FDA issued a decision of Substantially Equivalent on June 27, 2023. The device falls under product code HDX (Dilator, Vaginal), a Class II device regulated under 21 CFR 884.3900. Lujena, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 27, 2023
- Date Received
- August 17, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dilator, Vaginal
- Device Class
- Class II
- Regulation Number
- 884.3900
- Review Panel
- OB
- Submission Type