FAQ 302

GUDID 07640260120297

FAQ 302 is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of Ila-V and females with androgenetic alopecia who have Ludwig-Savin Classifications of l-II and Fitzpatrick Classification of Skin Phototypes I to IV.

Foreo AB

Hair growth laser device

• Primary Device ID: 07640260120297
• NIH Device Record Key: 6d5d0404-a8f9-4bc2-9b2d-5aba8d921934
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FAQ 302
• Version Model Number: Black Diamond
• 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	07640260120297 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242747

FDA Product Code

• OAP: Laser, Comb, Hair

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: 2024-12-27
• Device Publish Date: 2024-12-19

Devices Manufactured by Foreo AB

• 07640260120297 - FAQ 302: 2024-12-27FAQ 302 is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of Ila-V and females with androgenetic alopecia who have Ludwig-Savin Classifications of l-II and Fitzpatrick Classification of Skin Phototypes I to IV.
• 07640260120297 - FAQ 302: 2024-12-27 FAQ 302 is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of Ila
• 07350120791238 - Luna 4 Plus: 2024-10-04 Luna 4 plus is a Near-Infrared Heated Cleansing Device With Red LED light & Microcurrent Massage Microcurrent: indicated for fac
• 07350120791245 - Luna 4 Plus: 2024-10-04 Luna 4 plus is a Near-Infrared Heated Cleansing Device With Red LED light & Microcurrent Massage Microcurrent: indicated for fac
• 07350120792693 - PEACH 2 pro max: 2024-08-16 PEACH 2 pro max is an over-the-counter device intended for the removal of unwanted body hair and/or facial hair.
• 07350120791900 - PEACH 2 go: 2024-08-15 PEACH™ 2 go is an over-the-counter device intended for the removal of unwanted body hair and/or facial hair.
• 07350120791917 - PEACH 2 go: 2024-08-15 PEACH™ 2 go is an over-the-counter device intended for the removal of unwanted body hair and/or facial hair.
• 07350120790521 - ESPADA 2: 2024-08-14 The ESPADA 2 Acne-Clearing Blue Light Pen is intended for use as an at-home device for the treatment of mild to moderate inflam
• 07350120790538 - ESPADA 2: 2024-08-14 The ESPADA 2 Acne-Clearing Blue Light Pen is intended for use as an at-home device for the treatment of mild to moderate inflam