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FDA 510(k)

Solevy Co. LLC Water-Based Personal Lubricant

K-Number: K203654 · 2021-04-19

ApplicantSolevy Co., LLC
Decision Date2021-04-19
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Solevy Co. LLC Water-Based Personal Lubricant is a medical device manufactured by Solevy Co., LLC. It received FDA 510(k) clearance on 2021-04-19 under approval number K203654. 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 Solevy Co. LLC Water-Based Personal Lubricant?

Solevy Co. LLC Water-Based Personal Lubricant is a medical device that received FDA 510(k) clearance on 2021-04-19. It is manufactured by Solevy Co., LLC. The 510(k) number is K203654.

When was Solevy Co. LLC Water-Based Personal Lubricant approved by the FDA?

Solevy Co. LLC Water-Based Personal Lubricant received FDA 510(k) clearance on 2021-04-19, under approval number K203654.

What company makes Solevy Co. LLC Water-Based Personal Lubricant?

Solevy Co. LLC Water-Based Personal Lubricant is manufactured by Solevy Co., LLC.

What is the FDA product code for Solevy Co. LLC Water-Based Personal Lubricant?

The FDA product code for Solevy Co. LLC Water-Based Personal Lubricant is NUC.

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Related PubMed Literature

PMID: 41488933 A narrative review on the environmental impact of medicines: from water analysis and Frontiers in drug safety and regulation (2025)

Other Devices by Solevy Co., LLC

K203644Solevy Co. LLC Silicone Based Personal Lubricant

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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.

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