Celluma CDLX-001

GUDID 00850523007129

3 mode full body panel

BIOPHOTAS, INC.

Blue/red/infrared phototherapy lamp

• Primary Device ID: 00850523007129
• NIH Device Record Key: ae0a3b12-78f9-44a6-a079-ad98debb8899
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Celluma
• Version Model Number: DELUX C/US
• Catalog Number: CDLX-001
• Company DUNS: 063400364
• Company Name: BIOPHOTAS, INC.
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850523007129 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171323

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-07-07
• Device Publish Date: 2020-06-11

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