PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)— 510(k) K261292

Name: FDA 510(k) clearance K261292
Creator: U.S. Food and Drug Administration
Published: 2026-06-11

Substantially Equivalent

PR Personal Care Laboratories

FDA 510(k) clearance K261292 for PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant), Substantially Equivalent on 2026-06-11. Applicant: PR Personal Care Laboratories. Device class: 2.

Summary

PR Personal Care Laboratories' PR Water-Base Lube Personal Lubricant is filed under NUC, personal lubricants. The water-based description comes from the device name; the record doesn't list ingredients.

Class II, 21 CFR 884.5300. Obstetrics/Gynecology is both the classification panel and the review panel. The submission was a Traditional 510(k).

PR Personal Care filed from Valencia, California. The decision came 52 calendar days after receipt (April 20 to June 11, 2026).

Clearance details

Applicant: PR Personal Care Laboratories
Product code: Product code NUC
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2026-04-20
Decision date: 2026-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valencia, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NUC

view all

K260117 — Everslide2026-09-23
K253989 — HARU Orgasm by jack herer water based lubricant (WL-OJ) +2 more2026-09-03
K261905 — BUM Oil2026-08-07
K261177 — PINKSLIP Water-Based Personal Lubricant and Moisturizer2026-07-09
K261909 — Plum Vagiceuticals Vaginal Moisturizing Suppositories2026-07-06

Adverse events under product code NUC

product code NUC

Other: 8
Total: 8

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.