# K213220: Revaree Plus Vaginal Suppositories

- Pathway: 510(k) (Traditional)
- Applicant: Farma-Derma S.R.L.
- Decided: Jun 21, 2022 after 265 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). 6 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153372: Repagyn vaginal suppositories, Farma-Derma S.R.L. (2016) Summary page 5.

## Most influential descendants
- K261909: Plum Vagiceuticals™ Vaginal Moisturizing Suppositories (2026), 0 descendants of its own
- K260007: Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg) (2026), 0 descendants of its own
- K230518: HydraDose Vaginal Suppositories (2023), 0 descendants of its own

## Indications for use
Revaree plus vaginal suppositories are 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, polyurethane, and polyisoprene condoms.

Source page: https://510kreport.com/device/K213220
Methodology: https://510kreport.com/methodology