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510(k) Data Aggregation
K Number
K020973Device Name
EX-308 EXCIMER LASER FOR PHOTOTHERAPY TREATMENT OF VITILIGO
Manufacturer
SURGILIGHT, INC.
Date Cleared
2002-03-29
(3 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SURGILIGHT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SurgiLight, Inc. EX-308 Excimer laser, handpieces and laser related accessories is indicated for use for the treatment of psoriasis and for the treatment of vitiligo.
Device Description
The SurgiLight EX-308 Excimer Laser is a medical device that is capable of emitting a treatment laser beam at a wavelength of 308nm under the quidance of a visible aiming beam. This laser may be used in a pulsed mode at various repetition rates.
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K Number
K993328Device Name
SURGILIGHT, INC EXCIMER LASER
Manufacturer
SURGILIGHT, INC.
Date Cleared
2000-07-18
(288 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SURGILIGHT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SurgiLight, Inc. EX-308 Excimer laser, handpieces and laser related accessories will be indicated for use for the treatment of psoriasis. These indications have been cleared for marketing by the Food and Drug Administration for the cited predicated devices. SurgiLight, Inc. seeks no new indications for the EX-308 Excimer Laser.
Device Description
The SurgiLight EX-308 Excimer Laser is a medical device that is capable of emitting a treatment laser beam at a wavelength of 308nm under the guidance of a visible aiming beam. This laser may be used in a pulsed mode at various repetition rates.
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