# BTL Industries, Inc.

- Location (FDA's records): Marlborough, MA
- FDA decisions: 47 (2009–2026): 47 510(k) clearances
- Names in FDA's records: BTL Industries, Inc. (44); Btl Industries, Ltd. (3)
- Product codes: GEI (14), PBX (5), NGX (4), KPI (4), IPF (3), IMJ (3), OBP (2), GEX (2), NFO (2), QCI (1), ISA (1), NUW (1)
- 510(k) review time since 2016: median 140 days, against 130 for FDA's reviews in the same codes and years (16 of 31 faster)
- Predicates its devices cite: 78 (29 its own); citations of its devices by later devices: 59 (29 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
- Tonica Elektronik A/S: 5 (https://510kreport.com/company/tonica-elektronik-a-s)
- Thermage, Inc.: 3 (https://510kreport.com/company/thermage)
- Alma Lasers, Inc.: 3 (https://510kreport.com/company/alma-lasers)
- Btl: 3 (https://510kreport.com/company/btl)
- Chattanooga Group, Inc.: 3 (https://510kreport.com/company/chattanooga-group)
- Syneron Medical, Ltd.: 2 (https://510kreport.com/company/syneron-medical)
- Ellman Int'L, Inc.: 2 (https://510kreport.com/company/ellman-int-l)
- Zimmer Medizinsysteme GmbH: 2 (https://510kreport.com/company/zimmer-medizinsysteme)

## Firms that cite its devices most
- Zimmer Medizinsysteme GmbH: 4 (https://510kreport.com/company/zimmer-medizinsysteme)
- Btl: 4 (https://510kreport.com/company/btl)
- Nanjing Vishee Medical Technology Co., Ltd.: 2 (https://510kreport.com/company/nanjing-vishee-medical-technology)
- Lutronic Corporation: 1 (https://510kreport.com/company/lutronic)
- El..En. Electroic Engineering Spa: 1 (https://510kreport.com/company/el-en-electroic-engineering)
- Pontemedag: 1 (https://510kreport.com/company/pontemedag)
- Beijing Adss Development Co., Ltd.: 1 (https://510kreport.com/company/beijing-adss-development)
- Bios S.R.L.: 1 (https://510kreport.com/company/bios)

## Its most-cited devices
- K181497: HPM-6000UF (2018), cited by 6
- K180813: BTL 799-2 (2018), cited by 6
- K092191: Exilis, Model 5000 (2009), cited by 5
- K160992: HPM-6000 (2016), cited by 5
- K190456: BTL 799-2L (2019), cited by 5
- K143040: Exilis XP (2015), cited by 4

## Recent decisions
- K262353: BTL-299-F (Sep 23, 2026)
- K260691: BTL-699 (Aug 23, 2026)
- K252963: BTL-899TT (Jun 12, 2026)
- K253750: BTL-785NEH (Mar 17, 2026)
- K252561: BTL-754FF (Feb 18, 2026)
- K250309: BTL-199 (Aug 7, 2025)
- K243290: BTL-785MJ (May 9, 2025)
- K241516: BTL-398 (Feb 10, 2025)

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