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FDA 510(k)

Play&Joy InvisiLube Lubricant Capsule

K-Number: K220646 · 2023-07-10

ApplicantInnovemed Bio-Tech Co., Ltd.
Decision Date2023-07-10
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Play&Joy InvisiLube Lubricant Capsule is the device name listed in this FDA 510(k) record. The listed applicant is Innovemed Bio-Tech Co., Ltd.. It received FDA 510(k) clearance on 2023-07-10 under 510(k) number K220646. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Play&Joy InvisiLube Lubricant Capsule?

Play&Joy InvisiLube Lubricant Capsule is a medical device that received FDA 510(k) clearance on 2023-07-10. The listed applicant is Innovemed Bio-Tech Co., Ltd.. The 510(k) number is K220646.

When did Play&Joy InvisiLube Lubricant Capsule receive FDA 510(k) clearance?

Play&Joy InvisiLube Lubricant Capsule received FDA 510(k) clearance on 2023-07-10, under 510(k) number K220646.

Who is the listed applicant for Play&Joy InvisiLube Lubricant Capsule?

The FDA 510(k) record lists Innovemed Bio-Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Play&Joy InvisiLube Lubricant Capsule?

The FDA product code for Play&Joy InvisiLube Lubricant Capsule is NUC.

Other records listing Innovemed Bio-Tech Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221137Play and Joy Water-Based Lubricant

Related Devices (Code: NUC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261905BUM OilBumlicious, LLC (DBA “Bumlicious”)K261177PINKSLIP Water-Based Personal Lubricant and MoisturizerPINKSLIP, LLCK261909Plum Vagiceuticals™ Vaginal Moisturizing SuppositoriesPCCA, Inc.K254011Flow Water-Based Personal LubricantLBDO Group, Inc.K261292PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)PR Personal Care LaboratoriesK252914Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)Hathor Professional Skincare , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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