PROLITE PULSED LIGHT SYSTEM FOR THE TREATMENT OF PIGMENTED LESIONS AND THE REMOVAL OF TATTOOS
FDA 510(k) clearance K013365 · decided 2002-01-08
Clearance details
- K-number
- K013365
- Device name
- PROLITE PULSED LIGHT SYSTEM FOR THE TREATMENT OF PIGMENTED LESIONS AND THE REMOVAL OF TATTOOS
- Applicant
- Medical Bio Care Sweden AB
- Decision
- Substantially Equivalent
- Date received
- 2001-10-10
- Decision date
- 2002-01-08
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Woodland, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.