The following data is part of a premarket notification filed by Hill Laboratories Co. with the FDA for Electro-light Therapy.
Device ID | K090250 |
510k Number | K090250 |
Device Name: | ELECTRO-LIGHT THERAPY |
Classification | Lamp, Infrared, Therapeutic Heating |
Applicant | HILL LABORATORIES CO. 3 BACTON HILL RD. Frazer, PA 19355 |
Contact | Brady Aller |
Correspondent | Brady Aller HILL LABORATORIES CO. 3 BACTON HILL RD. Frazer, PA 19355 |
Product Code | ILY |
CFR Regulation Number | 890.5500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-02-02 |
Decision Date | 2010-02-11 |
Summary: | summary |