PROLITE PULSED LIGHT SYSTEM— 510(k) K000929
Substantially EquivalentMedical Bio Care Sweden AB
FDA 510(k) clearance K000929 for PROLITE PULSED LIGHT SYSTEM, Substantially Equivalent on 2000-10-17. Applicant: Medical Bio Care Sweden AB. Device class: 2.
Clearance details
- Applicant
- Medical Bio Care Sweden AB
- Product code
- Code GEX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Albuquerque,, NM, US
Recent devices under product code GEX
view allMore clearances from Medical Bio Care Sweden AB
view all- K023081 — PROLITE / PLASMALITE MPX PULSED LIGHT SYSTEM (PERMANENT HAIR REDUCTION)
- K022378 — PLASMALITE PULSED LIGHT SYSTEM
- K022568 — PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF UNWANTED HAIR
- K022569 — PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF VASCULAR LESIONS
- K013365 — PROLITE PULSED LIGHT SYSTEM FOR THE TREATMENT OF PIGMENTED LESIONS AND THE REMOVAL OF TATTOOS
Adverse events under product code GEX
product code GEX- Death
- 33
- Injury
- 3,045
- Malfunction
- 12,903
- Other
- 25
- Total
- 16,006
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.