Home / 510(k) Clearances / K200527

510(k) K200527

pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based, pjur med Moisturising glide,pjur med NATURAL glide, We-Vibe Lube made by pjur by Pjur Group Luxembourg S.A. — Product Code NUC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 2021
Date Received
March 2, 2020
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 Pjur Group Luxembourg S.A.

  • K260068 — pjur NATURE Touch, 100 ml (May 21, 2026)
  • K200731 — pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR a (January 21, 2021)
  • K200730 — pjur WOMAN Nude pjur med SENSITIVE glide (December 17, 2020)
  • K141913 — PJUR SILICONE BASED LUBRICANT: PJUR BACKDOOR ANAL GLIDE AND ANALYSE ME! (April 6, 2015)
  • K133336 — PJUR(R) SILICONEGEL, PJUR(R) BASIC PERSONAL GLIDE, PJUR(R) LIGHT, PJUR(R) MED PR (July 24, 2014)
  • K133233 — PJUR ORIGINAL, PJUR WOMAN, PJUR MAN EXTREME GLIDE (July 18, 2014)

Other clearances for product code NUC

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  • K252914 — Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) (June 9, 2026)
  • K260068 — pjur NATURE Touch, 100 ml (May 21, 2026)
  • K254101 — Julva Velvé Water-Based Personal Lubricant (April 16, 2026)
  • K260007 — Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Supposito (April 1, 2026)
  • 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)