# Medical Bio Care Sweden AB

- Location (FDA's records): Woodland, CA
- FDA decisions: 10 (2000–2002): 10 510(k) clearances
- Product codes: GEX (10)
- Predicates its devices cite: 5 (3 its own); citations of its devices by later devices: 21 (3 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
- Esc Medical Systems, Ltd.: 2 (https://510kreport.com/company/esc-medical-systems)

## Firms that cite its devices most
- Altus Medical, Inc.: 8 (https://510kreport.com/company/altus-medical)
- Luxsano AB: 4 (https://510kreport.com/company/luxsano)
- Mccue Plc: 3 (https://510kreport.com/company/mccue)
- New Star Lasers, Inc.: 2 (https://510kreport.com/company/new-star-lasers)
- Hair International Systems USA, Inc.: 1 (https://510kreport.com/company/hair-international-systems-usa)

## Its most-cited devices
- K013365: Prolite Pulsed Light System for the Treatment of Pigmented Lesions and the Removal of Tattoos (2002), cited by 4
- K022568: Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair (2002), cited by 4
- K013366: Prolite Pulsed Light System for the Removal of Unwanted Hair (2002), cited by 3
- K023081: Prolite / Plasmalite MPX Pulsed Light System (Permanent Hair Reduction) (2002), cited by 3
- K022569: Prolite/Plasmalite MPX Pulsed Light System for Treatment of Vascular Lesions (2002), cited by 2
- K010928: Prolite VL Pulsed Light System (2001), cited by 2

## Recent decisions
- K023081: Prolite / Plasmalite MPX Pulsed Light System (Permanent Hair Reduction) (Dec 16, 2002)
- K022378: Plasmalite Pulsed Light System (Oct 18, 2002)
- K022569: Prolite/Plasmalite MPX Pulsed Light System for Treatment of Vascular Lesions (Aug 29, 2002)
- K022568: Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair (Aug 29, 2002)
- K013366: Prolite Pulsed Light System for the Removal of Unwanted Hair (Jan 8, 2002)
- K013365: Prolite Pulsed Light System for the Treatment of Pigmented Lesions and the Removal of Tattoos (Jan 8, 2002)
- K010927: Modification to Prolite Pulsed Light System (Jun 19, 2001)
- K010928: Prolite VL Pulsed Light System (Jun 19, 2001)

Source page: https://510kreport.com/company/medical-bio-care-sweden