# K120481: Lil-Lets Silk Comfort Compact, Plastic Applicator, Lite, Regular, Super, Super Plus and Ultra Lil-Lets Non Applicator,

- Pathway: 510(k) (Special)
- Applicant: Tosama, D.O.O.
- Decided: Jul 13, 2012 after 148 days
- Product code: HEB (Tampon, Menstrual, Unscented)
- Device class: 2
- Regulation: 21 CFR 884.5470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K080775 (2008). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080775: Maxim Plastic Applicator & Non-Applicator Tampons, Tosama D.D. (2008) Summary page 1.

## Indications for use
The Lul-lets tampons (both types) are unscented tampons for: - Women's personal hygiene with respect to intra vaginal absorption of menstrual or other vaginal discharge. * The plastic applicator is for easing the placement of the tampon correctly into the vagina (only the Lil-lets Silk Comfort Compact Plastic Applicator Tampon).

Source page: https://510kreport.com/device/K120481
Methodology: https://510kreport.com/methodology