# Theradome, Inc.

- Location (FDA's records): Pleasanton, CA
- FDA decisions: 5 (2012–2018): 5 510(k) clearances
- Product codes: OAP (5)
- 510(k) review time since 2016: median 87 days, against 87 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 9 (5 its own); citations of its devices by later devices: 14 (5 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
- Midwest Rf, LLC: 2 (https://510kreport.com/company/midwest-rf)
- Apira Science, Inc.: 1 (https://510kreport.com/company/apira-science)
- Lexington International, LLC: 1 (https://510kreport.com/company/lexington-international)

## Firms that cite its devices most
- Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC: 2 (https://510kreport.com/company/pjm-worldwide-d-b-a-phoenix-medical-technology)
- Sunetics International Marketing Group, LLC: 2 (https://510kreport.com/company/sunetics-international-marketing-group)
- Capillus, LLC: 2 (https://510kreport.com/company/capillus)
- Transdermal Cap, Inc.: 1 (https://510kreport.com/company/transdermal-cap)
- Photonmd, Inc.: 1 (https://510kreport.com/company/photonmd)
- Hairlabs International, Inc.: 1 (https://510kreport.com/company/hairlabs-international)

## Its most-cited devices
- K122950: Laser Helmet (2013), cited by 8
- K113097: Laser Helmet (2012), cited by 4
- K161046: Laser Helmet LH40-EVO (2016), cited by 1
- K171775: Theradome LH80 PRO (2018), cited by 1

## Recent decisions
- K180460: Theradome LH40 (May 18, 2018)
- K171775: Theradome LH80 PRO (Jan 9, 2018)
- K161046: Laser Helmet LH40-EVO (May 12, 2016)
- K122950: Laser Helmet (Jun 14, 2013)
- K113097: Laser Helmet (Mar 2, 2012)

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