# Pulsaderm, LLC

- Location (FDA's records): Fort Myers, FL
- FDA decisions: 3 (2017–2018): 3 510(k) clearances
- Product codes: OHS (1), OLP (1), OAP (1)
- 510(k) review time since 2016: median 116 days, against 133 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 4 (0 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
- La Lumiere, LLC: 2 (https://510kreport.com/company/la-lumiere)
- Silverbay, LLC, D/B/A Quasar Bio-Tech: 1 (https://510kreport.com/company/silverbay-d-b-a-quasar-bio-tech)
- Nutra Luxe MD, LLC: 1 (https://510kreport.com/company/nutra-luxe-md)

## Firms that cite its devices most
- Biophotas, Inc.: 1 (https://510kreport.com/company/biophotas)
- Lg Electronics.Inc: 1 (https://510kreport.com/company/lg-electronics)
- Gtg Wellness Co., Ltd.: 1 (https://510kreport.com/company/gtg-wellness)
- Johnson & Johnson Consumer, Inc.: 1 (https://510kreport.com/company/johnson-johnson-consumer)

## Its most-cited devices
- K163329: Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 (2017), cited by 3
- K170111: Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37 (2017), cited by 1

## Recent decisions
- K182501: Hair Laser Headband (Oct 26, 2018)
- K170111: Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37 (May 8, 2017)
- K163329: Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 (Apr 14, 2017)

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