Smooth Beauty Eye Wrinkle Laser 3503

GUDID B5863503

Tria Beauty

Laser skin surface treatment system applicator Laser skin surface treatment system applicator Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece

• Primary Device ID: B5863503
• NIH Device Record Key: cc8f4ede-bc2e-4183-8a34-860e256f114c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smooth Beauty Eye Wrinkle Laser
• Version Model Number: FANp
• Catalog Number: 3503
• Company DUNS: 080705345
• Company Name: Tria Beauty
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-877-321-8742
• Email: customercare@triabeauty.com
• Phone: 1-877-321-8742
• Email: customercare@triabeauty.com
• Phone: 1-877-321-8742
• Email: customercare@triabeauty.com
• Phone: 1-877-321-8742
• Email: customercare@triabeauty.com
• Phone: 1-877-321-8742
• Email: customercare@triabeauty.com
• Phone: 1-877-321-8742
• Email: customercare@triabeauty.com
• Phone: 1-877-321-8742
• Email: customercare@triabeauty.com
• Phone: 1-877-321-8742
• Email: customercare@triabeauty.com
• Phone: 1-877-321-8742
• Email: customercare@triabeauty.com
• Phone: 1-877-321-8742
• Email: customercare@triabeauty.com
• Phone: 1-877-321-8742
• Email: customercare@triabeauty.com
• Phone: 1-877-321-8742
• Email: customercare@triabeauty.com
• Phone: 1-877-321-8742
• Email: customercare@triabeauty.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B5863503 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141868

FDA Product Code

• ONG: Powered Laser Surgical Instrument With Microbeam\Fractional Output

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-26

Devices Manufactured by Tria Beauty

• B58613752 - Skin Renu Laser: 2020-07-21 Skin Renu Laser
• B5863159 - HAIR REMOVAL LASER: 2020-07-21 Hair Removal Laser 4X, White with Green - Korea
• B5863192 - HAIR REMOVAL LASER: 2020-07-21 Hair Removal Laser 4X, White with Fuchsia - Korea
• B5863386 - Positively Clear Acne Clearing Blue Light: 2020-07-21 Positively Clear Acne Clearing Blue Light - Korea
• B5863634 - Hair Removal Laser Precisison: 2020-07-21 Hair Removal Laser Precision - White - Korea
• B5863725 - HAIR REMOVAL LASER: 2020-07-21 Hair Removal Laser 4X, White with Grey
• B5863724 - HAIR REMOVAL LASER: 2018-07-23 Hair Removal Laser 4X, White with Fuchsia
• B5863374 - Positively Clear: 2018-07-16