PROLITE PULSED LIGHT SYSTEM FOR THE TREATMENT OF PIGMENTED LESIONS AND THE REMOVAL OF TATTOOS— 510(k) K013365
Substantially EquivalentMedical Bio Care Sweden AB
FDA 510(k) clearance K013365 for PROLITE PULSED LIGHT SYSTEM FOR THE TREATMENT OF PIGMENTED LESIONS AND THE REMOVAL OF TATTOOS, Substantially Equivalent on 2002-01-08. 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
- Woodland, CA, 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
- K013366 — PROLITE PULSED LIGHT SYSTEM FOR THE REMOVAL OF UNWANTED HAIR
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.