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FDA 510(k)

Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)

K-Number: K252914 · 2026-06-09

ApplicantHathor Professional Skincare , Ltd.
Decision Date2026-06-09
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) is the device name listed in this FDA 510(k) record. The listed applicant is Hathor Professional Skincare , Ltd.. It received FDA 510(k) clearance on 2026-06-09 under 510(k) number K252914. 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 Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)?

Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) is a medical device that received FDA 510(k) clearance on 2026-06-09. The listed applicant is Hathor Professional Skincare , Ltd.. The 510(k) number is K252914.

When did Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) receive FDA 510(k) clearance?

Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) received FDA 510(k) clearance on 2026-06-09, under 510(k) number K252914.

Who is the listed applicant for Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)?

The FDA 510(k) record lists Hathor Professional Skincare , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)?

The FDA product code for Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) is NUC.

Other records listing Hathor Professional Skincare , 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.

K250629Sutil Rich Personal LubricantK241443Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118)

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 LaboratoriesK260068pjur NATURE Touch, 100 mlPjur Group Luxembourg S.A.

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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