Home / 510(k) Clearances / K241443

510(k) K241443

Sutil 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) by Hathor Professional Skincare , Ltd. — Product Code NUC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 2025
Date Received
May 22, 2024
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 Hathor Professional Skincare , Ltd.

  • K250629 — Sutil Rich Personal Lubricant (May 2, 2025)

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)