← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

NUCLubricant, Personal

This device is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms.

DEVICE CLASS
Class II
REGULATION
21 CFR 884.5300
MEDICAL SPECIALTY
Obstetrics/Gynecology
REVIEW PANEL
OB
ImplantLife-sustainingGMP-exemptThird-party review eligible
23
510(K)/PMA CLEARANCES
510k: 23
0
RECALL ENTRIES

Recent clearances

K261177PINKSLIP, LLC · 510k2026-07-09
K261909PCCA, Inc. · 510k2026-07-06
K254011LBDO Group, Inc. · 510k2026-06-22
K261292PR Personal Care Laboratories · 510k2026-06-11
K252914Hathor Professional Skincare , Ltd. · 510k2026-06-09
K260068Pjur Group Luxembourg S.A. · 510k2026-05-21
K254101Golden Isles Medical, Inc. · 510k2026-04-16
K260007Hudi Pharma Srl · 510k2026-04-01

Related on SPEQ

Medical devices industryMedical device quality (ISO 13485)FDA device clearancesFDA enforcement & recalls

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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