Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Belle Sensilube

K-Number: K230781 · 2023-06-20

ApplicantRb Health (Us), LLC
Decision Date2023-06-20
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Belle Sensilube is the device name listed in this FDA 510(k) record. The listed applicant is Rb Health (Us), LLC. It received FDA 510(k) clearance on 2023-06-20 under 510(k) number K230781. 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 Belle Sensilube?

Belle Sensilube is a medical device that received FDA 510(k) clearance on 2023-06-20. The listed applicant is Rb Health (Us), LLC. The 510(k) number is K230781.

When did Belle Sensilube receive FDA 510(k) clearance?

Belle Sensilube received FDA 510(k) clearance on 2023-06-20, under 510(k) number K230781.

Who is the listed applicant for Belle Sensilube?

The FDA 510(k) record lists Rb Health (Us), LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Belle Sensilube?

The FDA product code for Belle Sensilube is NUC.

Other records listing Rb Health (Us), LLC 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.

K241617Durex Polyisoprene CondomK213892Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & MineK220489Durex Patronus CloseFit, Durex Patronus RegularK222068Durex Penck III RegularK211152Durex Condom with BenzocaineK213400Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry

View all 15 devices →

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

View on FDA Database →

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

↑