PEACH 2

GUDID 07350120791436

PEACH™ 2 is an over-the-counter device intended for the removal of unwanted body hair and/or facial hair

Foreo AB

Home-use intense pulsed light hair removal unit

• Primary Device ID: 07350120791436
• NIH Device Record Key: 8fa8c604-1ff1-4633-bbb5-5ad442fefb9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PEACH 2
• Version Model Number: Mint
• Company DUNS: 352394143
• Company Name: Foreo AB
• 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	07350120791436 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231977

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: 2024-03-08
• Device Publish Date: 2024-02-29

On-Brand Devices [PEACH 2 ]

• 07350120791887: PEACH™ 2 is an over-the-counter device intended for the removal of unwanted body hair and/or f
• 07350120791436: PEACH™ 2 is an over-the-counter device intended for the removal of unwanted body hair and/or f