Clearance Summary
Play&Joy InvisiLube Lubricant Capsule received FDA 510(k) clearance under submission number K220646, sponsored by Innovemed Bio-Tech Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2023-07-10.
- Submission: K220646
- Applicant / Sponsor: Innovemed Bio-Tech Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2023-07-10
Classification & Regulation
This clearance is catalogued under FDA product code NUC and 21 CFR 884.5300, within the Obstetrics/Gynecology review panel as a Class II device.