# K211998: Desnuda Reflect

- Pathway: 510(k) (Traditional)
- Applicant: Good Clean Love, Inc.
- Decided: Nov 18, 2021 after 143 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: 5 generations back to K810310 (1981). 12 ancestors in all.
6 later devices descend from it; 5 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150883: HyaloGYN Vaginal Hydrating Gel, Fidia Farmaceutici S.P.A. (2015) Summary page 4.

## Most influential descendants
- 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
- K254101: Julva Velvé Water-Based Personal Lubricant (2026), 0 descendants of its own

## Indications for use
Desnuda Reflect 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 is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Source page: https://510kreport.com/device/K211998
Methodology: https://510kreport.com/methodology