Cleared Traditional

K140506 - JOY DROPS (TM) NATURAL PERSONAL LUBRICANT GEL

K140506 is an FDA 510(k) clearance for JOY DROPS (TM) NATURAL PERSONAL LUBRICA..., manufactured by Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa. The device is a Class 2 Obstetrics & Gynecology device with product code NUC cleared through the Traditional 510(k) pathway after a 414-day FDA review.

K140506 · Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
414d
Days
Class 2
Risk

K140506 is an FDA 510(k) clearance for the JOY DROPS (TM) NATURAL PERSONAL LUBRICANT GEL. Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa (San Francisco, US). The FDA issued a Cleared decision on April 17, 2015 after a review of 414 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5300 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

FDA 510(k) Submission Details - K140506

510(k) Number K140506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2014
Decision Date April 17, 2015
Days to Decision 414 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
253d slower than avg
Panel avg: 161d · This submission: 414d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NUC Device Classification - Class 2, Special Controls

Product Code NUC Lubricant, Personal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5300
Definition 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - NUC Lubricant, Personal

All 248
Devices cleared under the same product code (NUC) and FDA review panel - the closest regulatory comparables to K140506.
JO H20 Water Based Personal Lubricant
K150480 · United Consortium, Inc. · Jul 2015
K-Y BRAND TOUCH All-in-one Warming Caressing Creme and Personal Lubricant
K143511 · Reckitt Benckiser · May 2015
Vaginal Moisturizing Gel
K150615 · Combe Incorporated · May 2015
PJUR SILICONE BASED LUBRICANT: PJUR BACKDOOR ANAL GLIDE AND ANALYSE ME!
K141913 · Pjur Group Luxembourg S.A. · Apr 2015
ID MILLENNIUM, ID MOMENTS SILICONE
K141767 · Westridge Laboratories, Inc. · Mar 2015
Lubrigyn cream
K150147 · Uniderm Farmaceutici Srl · Feb 2015