The following data is part of a premarket notification filed by Palomar Medical Products, Inc. with the FDA for Palomar Lightcube.
Device ID | K024179 |
510k Number | K024179 |
Device Name: | PALOMAR LIGHTCUBE |
Classification | Lamp, Infrared, Therapeutic Heating |
Applicant | PALOMAR MEDICAL PRODUCTS, INC. 131 KELEKENT LN. Cary, NC 27511 |
Contact | Marcy Moore |
Correspondent | Marcy Moore PALOMAR MEDICAL PRODUCTS, INC. 131 KELEKENT LN. Cary, NC 27511 |
Product Code | ILY |
CFR Regulation Number | 890.5500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-12-18 |
Decision Date | 2003-06-04 |
Summary: | summary |