Device
This is a Class II infrared therapeutic heating lamp (Product Code ILY, 21 CFR 890.5500) intended for localized heat therapy to relieve muscle pain, joint stiffness, and improve lo...
Manufacturer
SUNSHINE USA, LLC
SUNSHINE USA, LLC
Model: L24
Catalog: L24
DI: G710L240
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
Description
This is a Class II infrared therapeutic heating lamp (Product Code ILY, 21 CFR 890.5500) intended for localized heat therapy to relieve muscle pain, joint stiffness, and improve local blood circulation.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
280f774b-440a-4256-be09-60ae6222ce55
Distribution Status:
In Commercial Distribution
DUNS Number:
104258633
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
G710L240
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 65723
Name: Red/infrared light phototherapy unit
Definition:
An electrically-powered device designed to emit red light and infrared/near-infrared light for phototherapy primarily to accelerate healing of cutaneous/mucosal tissues and/or to treat musculoskeletal symptoms (e.g., pain, spasm, stiffness) through modification of cellular metabolism and/or improvement of blood flow. It may have various designs (e.g., hand-held, arched bar, flexible pad for adapting to body areas) and is intended for use in the home and clinical settings.
FDA Product Codes
ILY
Lamp, Infrared, Therapeutic Heating