Medical Device Manufacturer · US , Albuquerque, , NM

Medical Bio Care Sweden AB - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 2000

Recent clearances: PROLITE / PLASMALITE MPX PULSED LIGHT SYSTEM (PERMANENT HAIR REDUCTION), PLASMALITE PULSED LIGHT SYSTEM, PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF UNWANTED HAIR

View 10 510(k) Devices ↓
10
Total
10
Cleared
0
Denied

FDA 510(k) Regulatory Record - Medical Bio Care Sweden AB General & Plastic Surgery ✕

10 devices
1-10 of 10
Cleared Dec 16, 2002
PROLITE / PLASMALITE MPX PULSED LIGHT SYSTEM (PERMANENT HAIR REDUCTION)
K023081 · GEX
General & Plastic Surgery · 90d
Cleared Oct 18, 2002
PLASMALITE PULSED LIGHT SYSTEM
K022378 · GEX
General & Plastic Surgery · 88d
Cleared Aug 29, 2002
PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF UNWANTED HAIR
K022568 · GEX
General & Plastic Surgery · 27d
Cleared Aug 29, 2002
PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF VASCULAR LESIONS
K022569 · GEX
General & Plastic Surgery · 27d
Cleared Jan 08, 2002
PROLITE PULSED LIGHT SYSTEM FOR THE TREATMENT OF PIGMENTED LESIONS AND THE...
K013365 · GEX
General & Plastic Surgery · 90d
Cleared Jan 08, 2002
PROLITE PULSED LIGHT SYSTEM FOR THE REMOVAL OF UNWANTED HAIR
K013366 · GEX
General & Plastic Surgery · 90d
Cleared Jun 19, 2001
MODIFICATION TO PROLITE PULSED LIGHT SYSTEM
K010927 · GEX
General & Plastic Surgery · 83d
Cleared Jun 19, 2001
PROLITE VL PULSED LIGHT SYSTEM
K010928 · GEX
General & Plastic Surgery · 83d
Cleared Oct 17, 2000
PROLITE PULSED LIGHT SYSTEM
K000929 · GEX
General & Plastic Surgery · 209d
Cleared Sep 11, 2000
PROLITE VL PULSED LIGHT SYSTEM
K002072 · GEX
General & Plastic Surgery · 66d
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