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)

Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant

K-Number: K200602 · 2020-06-03

ApplicantCC Wellness, LLC
Decision Date2020-06-03
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant is the device name listed in this FDA 510(k) record. The listed applicant is CC Wellness, LLC. It received FDA 510(k) clearance on 2020-06-03 under 510(k) number K200602. 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 Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant?

Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant is a medical device that received FDA 510(k) clearance on 2020-06-03. The listed applicant is CC Wellness, LLC. The 510(k) number is K200602.

When did Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant receive FDA 510(k) clearance?

Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant received FDA 510(k) clearance on 2020-06-03, under 510(k) number K200602.

Who is the listed applicant for Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant?

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

What is the FDA product code for Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant?

The FDA product code for Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant is NUC.

Other records listing CC Wellness, 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.

K232091JO Coconut Hybrid Cooling Personal LubricantK232090JO Coconut Hybrid Warming Personal LubricantK230674JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO Water Based Anal Thick Lubricant 8oz Model 40114K221908JO CUMPLAY Personal LubricantK212885Actively Trying Personal Lubricant Rose ScentedK212705Actively Trying Personal Lubricant Unfragrance

View all 12 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.

↑