# Tosama, D.O.O.

- Location (FDA's records): Vir, Domzale, SI
- FDA decisions: 5 (2012–2024): 5 510(k) clearances
- Product codes: HEB (5)
- Predicates its devices cite: 6 (1 its own); citations of its devices by later devices: 4 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Naturalena Brands, Inc.: 2 (https://510kreport.com/company/naturalena-brands)
- Cottons Pty, Ltd.: 1 (https://510kreport.com/company/cottons)
- Cotton High Tech S.L.: 1 (https://510kreport.com/company/cotton-high-tech)
- Tosama D.D.: 1 (https://510kreport.com/company/tosama-dd)

## Firms that cite its devices most
- Taebong Co., Ltd.: 1 (https://510kreport.com/company/taebong)
- Rael, Inc.: 1 (https://510kreport.com/company/rael)
- Zhejiang Tianqing Manufacturing Technology Group Co., Ltd.: 1 (https://510kreport.com/company/zhejiang-tianqing-manufacturing-technology-group)

## Its most-cited devices
- K151170: Tosama 100% Organic Cotton Menstrual Tampon (2015), cited by 4

## Recent decisions
- K232060: TOSAMA Reusable Applicator (Apr 12, 2024)
- K172504: Tosama Biobased Applicator Tube Menstrual Tampon (Feb 9, 2018)
- K151170: Tosama 100% Organic Cotton Menstrual Tampon (Jul 2, 2015)
- K150897: Tosama 100% Cotton Menstrual Tampon (Apr 20, 2015)
- K120481: Lil-Lets Silk Comfort Compact, Plastic Applicator, Lite, Regular, Super, Super Plus and Ultra Lil-Lets Non Applicator, (Jul 13, 2012)

Source page: https://510kreport.com/company/tosama-doo