Home / 510(k) Clearances / K210986

510(k) K210986

H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, #LubeLife Sensations Cooling, #LubeLife Sensations Pleasure Kit for Two, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit by CC Wellness, LLC — Product Code NUC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2021
Date Received
April 1, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lubricant, Personal
Device Class
Class II
Regulation Number
884.5300
Review Panel
OB
Submission Type

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.

Other clearances by CC Wellness, LLC

  • K232091 — JO Coconut Hybrid Cooling Personal Lubricant (October 22, 2023)
  • K232090 — JO Coconut Hybrid Warming Personal Lubricant (October 11, 2023)
  • K230674 — JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick L (May 8, 2023)
  • K221908 — JO CUMPLAY Personal Lubricant (September 20, 2022)
  • K212885 — Actively Trying Personal Lubricant Rose Scented (February 11, 2022)
  • K212705 — Actively Trying Personal Lubricant Unfragrance (February 9, 2022)
  • K210972 — H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tan (June 10, 2021)
  • K200894 — Agape Cooling Personal Lubricant (July 2, 2020)
  • K200602 — Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant (June 3, 2020)
  • K200457 — Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One W (May 22, 2020)

Other clearances for product code NUC

  • K253983 — Water-based lubricant (March 6, 2026)
  • K251011 — Chiavaye Personal Moisturizer (December 19, 2025)
  • K252935 — Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30 (December 15, 2025)
  • K250488 — Cerynë Intimate Care (December 12, 2025)
  • K251773 — Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin G (September 9, 2025)
  • K250142 — Water-based Lubricant (August 8, 2025)
  • K243972 — Plain Water-based Lubricant (August 8, 2025)
  • K242712 — LubriZenzs (June 4, 2025)
  • K243107 — Water Solubility Human Body Lubricant (May 9, 2025)
  • K250629 — Sutil Rich Personal Lubricant (May 2, 2025)