Philips Lumea IPL

GUDID 00075020107763

Philips Consumer Lifestyle B.V.

Home-use intense pulsed light hair removal unit

• Primary Device ID: 00075020107763
• NIH Device Record Key: 616c9f01-997a-4823-9fcb-5ad5c65aa7be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Philips Lumea IPL
• Version Model Number: BRI984
• Company DUNS: 489122720
• Company Name: Philips Consumer Lifestyle B.V.
• 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: true
• Serial Number: false
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00075020107763 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243453

FDA Product Code

• OHT: Light Based Over-The-Counter Hair Removal

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: 2025-07-28
• Device Publish Date: 2025-07-18

On-Brand Devices [Philips Lumea IPL]

• 00075020108494: BRI931
• 00075020108487: BRI932
• 00075020108425: BRI937
• 00075020107763: BRI984