Cleared Traditional

K150615 - Vaginal Moisturizing Gel

K150615 is an FDA 510(k) clearance for Vaginal Moisturizing Gel, manufactured by Combe Incorporated. The device is a Class 2 Obstetrics & Gynecology device with product code NUC cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K150615 · Combe Incorporated · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
52d
Days
Class 2
Risk

K150615 is an FDA 510(k) clearance for the Vaginal Moisturizing Gel. Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by Combe Incorporated (White Plains, US). The FDA issued a Cleared decision on May 1, 2015 after a review of 52 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Combe Incorporated devices

FDA 510(k) Submission Details - K150615

510(k) Number K150615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2015
Decision Date May 01, 2015
Days to Decision 52 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
108d faster than avg
Panel avg: 160d · This submission: 52d
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 213
Devices cleared under the same product code (NUC) and FDA review panel - the closest regulatory comparables to K150615.
Trojan Riviera Personal Lubricant
K150886 · Church & Dwight Co., Inc. · Jul 2015
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
JOY DROPS (TM) NATURAL PERSONAL LUBRICANT GEL
K140506 · Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa · Apr 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