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Psoria-ShieldJohn Yorke

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Atlanta1   Friday, 10/16/20 04:12:38 AM
Re: None
Post # of 1750 
Psoria-Shield
John Yorke
General Manager
409 Mandeville St
Utica, New York 13502
Re: K192411
Trade/Device Name: Psoria-Shield AURORA
Regulation Number: 21 CFR 878.4630
Regulation Name: Ultraviolet Lamp For Dermatologic Disorders
Regulatory Class: Class II
Product Code: FTC
Dated: June 1, 2020
Received: June 3, 2020
Dear John Yorke:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced
above and have determined the device is substantially equivalent (for the indications for use stated in the
enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the
enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance
with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a
premarket approval application (PMA). You may, therefore, market the device, subject to the general
controls provisions of the Act.



Psoria-Shield
John Yorke
General Manager
409 Mandeville St
Utica, New York 13502
Re: K192411
Trade/Device Name: Psoria-Shield AURORA
Regulation Number: 21 CFR 878.4630
Regulation Name: Ultraviolet Lamp For Dermatologic Disorders
Regulatory Class: Class II
Product Code: FTC
Dated: June 1, 2020
Received: June 3, 2020
Dear John Yorke:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced
above and have determined the device is substantially equivalent (for the indications for use stated in the
enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the
enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance
with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a
premarket approval application (PMA). You may, therefore, market the device, subject to the general
controls provisions of the Act.




https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192411.pdf


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