Medical Bio Care Sweden AB
Albuquerque, NM, US
Medical Bio Care Sweden AB appears in FDA device records in Albuquerque, NM. FDA records list 10 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 10
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 10 510(k) clearances for Medical Bio Care Sweden AB between 2000 and 2002. The busiest year on record is 2002, with 6. The most recent is 2002, with 6.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 2 |
| 2001 | 2 |
| 2002 | 6 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K023081 | PROLITE / PLASMALITE MPX PULSED LIGHT SYSTEM (PERMANENT HAIR REDUCTION) | GEX | Substantially Equivalent | |
| K022378 | PLASMALITE PULSED LIGHT SYSTEM | GEX | Substantially Equivalent | |
| K022569 | PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF VASCULAR LESIONS | GEX | Substantially Equivalent | |
| K022568 | PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF UNWANTED HAIR | GEX | Substantially Equivalent | |
| K013366 | PROLITE PULSED LIGHT SYSTEM FOR THE REMOVAL OF UNWANTED HAIR | GEX | Substantially Equivalent | |
| K013365 | PROLITE PULSED LIGHT SYSTEM FOR THE TREATMENT OF PIGMENTED LESIONS AND THE REMOVAL OF TATTOOS | GEX | Substantially Equivalent | |
| K010928 | PROLITE VL PULSED LIGHT SYSTEM | GEX | Substantially Equivalent | |
| K010927 | MODIFICATION TO PROLITE PULSED LIGHT SYSTEM | GEX | Substantially Equivalent | |
| K000929 | PROLITE PULSED LIGHT SYSTEM | GEX | Substantially Equivalent | |
| K002072 | PROLITE VL PULSED LIGHT SYSTEM | GEX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain