# K152507: Dr. Wolff Vagisan Moisturising Cream

- Pathway: 510(k) (Traditional)
- Applicant: Dr. August Wolff GmbH & Co. KG Arzeimittel
- Decided: May 20, 2016 after 261 days
- Product code: NUC (Lubricant, Personal)
- Device class: 2
- Regulation: 21 CFR 884.5300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K810310 (1981). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101098: Replens Long-Lasting Vaginal Moisturizer (35G Tube with Reusable Applicator) Model: 83035, Lil Drug Store Products, Inc. (2010) Summary page 4.

## Most influential descendants
- K193444: Vagisan MoistCream Cremolum (2020), 0 descendants of its own

## Indications for use
Vagisan® Moisturizing Cream is a personal lubricant for 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 is not compatible with natural rubber latex condoms and synthetic (polyurethane and polyisoprene) condoms.

Source page: https://510kreport.com/device/K152507
Methodology: https://510kreport.com/methodology