Sapphire

GUDID 00850001456029

Over the counter blue LED phototherapy device for the treatment of acne.

Omm Imports Inc.

Blue-light phototherapy lamp, home-use

• Primary Device ID: 00850001456029
• NIH Device Record Key: b5ac4d58-e6e7-4e03-97a6-9478cd76c4f5
• Commercial Distribution Discontinuation: 2031-07-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sapphire
• Version Model Number: S415
• Company DUNS: 010000704
• Company Name: Omm Imports Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850001456029 [Primary]

FDA Product Code

• OLP: Over-The-Counter Powered Light Based Laser For Acne

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: 2022-07-04
• Device Publish Date: 2022-06-24

Devices Manufactured by Omm Imports Inc.

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• 00850001456524 - Genesis Prime: 2024-09-05 Over the counter red/IR device for the treatment of wrinkles.
• 00850001456531 - Glorifico: 2024-09-05 Over the counter red/IR device for the treatment of wrinkles.
• 00850001456555 - Glorifico Plus: 2024-09-05 Over the counter red/IR device for the treatment of wrinkles.
• 00850001456647 - Genesis Skye: 2024-09-05 Over the counter blue LED phototherapy device for the treatment of acne.
• 00850001456678 - Elevare: 2024-09-05 Over the counter red/IR device for the treatment of wrinkles.
• 00850001456685 - Elevare Plus: 2024-09-05 Over the counter red/IR device for the treatment of wrinkles.
• 00850001456692 - Elevare Ivory: 2024-09-05 Over the counter blue LED phototherapy device for the treatment of acne.