# Btl

- Location (FDA's records): Marlborough, MA
- FDA decisions: 4 (2019–2021): 4 510(k) clearances
- Product codes: GEI (3), NGX (1)
- 510(k) review time since 2016: median 225 days, against 126 for FDA's reviews in the same codes and years (0 of 4 faster)
- Predicates its devices cite: 6 (1 its own); citations of its devices by later devices: 7 (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
- BTL Industries, Inc.: 4 (https://510kreport.com/company/btl-industries)
- Syneron Medical, Ltd.: 1 (https://510kreport.com/company/syneron-medical)

## Firms that cite its devices most
- BTL Industries, Inc.: 3 (https://510kreport.com/company/btl-industries)
- Shanghai Apolo Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/shanghai-apolo-medical-technology)
- InMode, Ltd.: 1 (https://510kreport.com/company/inmode)
- Capenergy Medical S.L.: 1 (https://510kreport.com/company/capenergy-medical)

## Its most-cited devices
- K200382: BTL-703-2 (2021), cited by 2
- K192224: BTL-899 (2019), cited by 2
- K202199: BTL-899ST (2021), cited by 2
- K193201: BTL-785F (2020), cited by 1

## Recent decisions
- K202199: BTL-899ST (Jan 26, 2021)
- K200382: BTL-703-2 (Jan 6, 2021)
- K193201: BTL-785F (Aug 21, 2020)
- K192224: BTL-899 (Dec 5, 2019)

Source page: https://510kreport.com/company/btl