LightStim for Acne / LightStim+ Acne

GUDID 00850030819031

LED INTELLECTUAL PROPERTIES LLC

Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable

• Primary Device ID: 00850030819031
• NIH Device Record Key: b3d5685d-10fe-4403-acca-d6f2f1ee225d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LightStim for Acne / LightStim+ Acne
• Version Model Number: LS4A / ALS-Pro
• Company DUNS: 963347211
• Company Name: LED INTELLECTUAL PROPERTIES LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850030819031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142246

FDA Product Code

• ILY: Lamp, Infrared, Therapeutic Heating

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-05
• Device Publish Date: 2022-06-27

Devices Manufactured by LED INTELLECTUAL PROPERTIES LLC

• 00850030819031 - LightStim for Acne / LightStim+ Acne: 2022-07-05
• 00850030819031 - LightStim for Acne / LightStim+ Acne: 2022-07-05
• 00850030819048 - LightStim for Wrinkles / LightStim+ Anti Aging: 2022-07-05
• 00850030819055 - LightStim+ ProPanel for Pain / Anti-Aging: 2022-07-05
• 00850030819062 - LightStim for Pain: 2022-07-05
• 00850030819079 - LightStim+ ProPanel for Acne: 2022-07-05
• 00850030819024 - LightStim & HydraFacial Elipsa: 2022-03-15 Light Therapy Device
• 00850030819017 - LightStim LED BED: 2021-06-24