Search Results
Found 4 results
510(k) Data Aggregation
K Number
K024189Device Name
NLITE SYSTEM, MODEL#: A00-1025/A00-1033
Manufacturer
ICN PHOTONICS LTD.
Date Cleared
2003-06-20
(183 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ICN PHOTONICS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NLite System is indicated for use in the specialties of Dermatology and Plastic Surgery, and in particular for the treatment of Inflammatory Acne Vulgaris`.
The NLite System is indicated for use in Dermatological and Plastic Surgery applications and this device is intended for use in the treatment of Inflammatory Acne Vulgaris.
Device Description
The NLite System is a flashlamp pumped, pulsed dye laser consisting of the following:
- Main laser console incorporating the laser resonator and external optics, high . voltage delivery system, internal cooler, fluid circulation system, control unit and user interface;
- Flexible fibre optic delivery device and optical handpiece; ●
- Footswitch for pulsing control. ●
Ask a Question
K Number
K020729Device Name
NLITE SYSTEM,MODEL A00-1051
Manufacturer
ICN PHOTONICS LTD.
Date Cleared
2002-06-04
(90 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ICN PHOTONICS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NLite System laser system is indicated for use in Dermatological and Plastic Surgery applications and this device is intended for use in the treatment of Vascular lesions, such as : Port Wine Stains, Telangiectasia, Leg Veins, Spider Veins, Spider Naevus, Poikiloderma of civatte, Hemangiomas, Angiomas, Rosacea
And benign cutaneous lesion, such as: Scars, Straie, Psoriasis, Verrucae Vulgaris and Warts.
Device Description
The NLite System is a flashlamp pumped, pulsed dye laser consisting of the following:
- Main laser console incorporating the laser resonator and external optics, high . voltage delivery system, internal cooler, fluid circulation system, control unit and user interface;
- Flexible fibre optic delivery device and optical handpiece; .
- Footswitch for pulsing control. .
Ask a Question
K Number
K013461Device Name
NLITE SYSTEM,MODEL A00-1025
Manufacturer
ICN PHOTONICS LTD.
Date Cleared
2002-01-17
(91 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ICN PHOTONICS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NLite System is indicated for use in the specialties of Dermatology and Plastic Surgery, and in particular for the treatment of wrinkles.
The NLite System is indicated for use in Dermatological and Plastic Surgery applications and this device is intended for use in the treatment of wrinkles.
Device Description
The NLite System is a flashlamp pumped, pulsed dye laser consisting of the following:
- Main laser console incorporating the laser resonator and external optics, high voltage delivery system, internal cooler, fluid circulation system, control unit and user interface;
- Flexible fibre optic delivery device and optical handpiece;
- Footswitch for pulsing control.
Ask a Question
K Number
K014130Device Name
NLITE SYSTEM
Manufacturer
ICN PHOTONICS LTD.
Date Cleared
2002-01-08
(22 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ICN PHOTONICS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NLite System is indicated for use in Dermatological and Plastic Sur ery applications and this device is intended for use in the trea ment of periocular wrinkles.
Device Description
NLite System
Ask a Question
Page 1 of 1