# K150883: HyaloGYN Vaginal Hydrating Gel

- Pathway: 510(k) (Traditional)
- Applicant: Fidia Farmaceutici S.P.A.
- Decided: Sep 1, 2015 after 152 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). 11 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K094039: Hyalo Gyn, Fidia Farmaceutici S.P.A. (2010) Summary page 4.
- K101098: Replens Long-Lasting Vaginal Moisturizer (35G Tube with Reusable Applicator) Model: 83035, Lil Drug Store Products, Inc. (2010) Summary page 4.
- K070587: Elegance Woman's Lubricant, Julie Williams, Pa-C (2008) Summary page 4.

## Most influential descendants
- K211998: Desnuda Reflect (2021), 6 descendants of its own
- 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) (2025), 1 descendant of its own
- K261177: PINKSLIP Water-Based Personal Lubricant and Moisturizer (2026), 0 descendants of its own
- K261292: PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant) (2026), 0 descendants of its own
- K252914: Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) (2026), 0 descendants of its own

## Indications for use
HyaloGYN® 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 compatible with polyisoprene condoms.

Source page: https://510kreport.com/device/K150883
Methodology: https://510kreport.com/methodology