Celluma CML2-001

GUDID 00850523007723

4 mode small panel light therapy device

BIOPHOTAS, INC.

Blue/red/infrared phototherapy lamp

• Primary Device ID: 00850523007723
• NIH Device Record Key: 0c1c3878-cf2f-482b-bff2-784a55e2ab02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Celluma
• Version Model Number: Series 2 LITE C/US
• Catalog Number: CML2-001
• Company DUNS: 063400364
• Company Name: BIOPHOTAS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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	00850523007723 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152280

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: 2024-12-30
• Device Publish Date: 2024-12-20

On-Brand Devices [Celluma]

• 00850523007402: Home
• 00850523007303: Elite C/US
• 00850523007204: Lite C/US
• 00850523007105: Pro C/US
• 00850523007600: 2-mode large panel
• 00850523007501: Hand held device 3-mode
• 00850523007181: 3 mode small panel
• 00850523007174: 3 mode large panel
• 00850523007143: 3 mode full body panel
• 00850523007129: 3 mode full body panel
• 00850523007075: 1 mode large panel
• 00850523007051: 2 mode small panel
• 00850523007037: 1-mode small panel
• 00850523007136: 3 mode device. Hair, Wrinkles, Aches & Pains
• 00850523007747: 2 mode small panel light therapy device
• 00850523007730: 3 mode small panel light therapy device
• 00850523007723: 4 mode small panel light therapy device
• 00850523007716: 3 mode large panel light therapy device
• 00850523007709: 4 mode large panel light therapy device
• 00850523007648: 1 mode large panel
• 00850523007938: 4 mode full body panel
• 00850523007891: 4 mode full body panel
• 00850523007808: 2-mode large panel
• 00850523007761: 5 Mode Light therapy device with capability of 3 Panels connected
• 00850523007754: 2 mode small panel
• 00850523007594: 4 Mode Light therapy device with capability of 3 Panels connected
• 00850075326044: 5 Model Low Level Light Therapy Device
• 00850075326006: 3 Panel 5 Mode Low Level Light Therapy Device