SMOOTHSKIN

GUDID 05060352782837

Light based Over-The-Counter Hair Removal

CYDEN LIMITED

Cosmetic red-light phototherapy system, home-use Cosmetic red-light phototherapy system, home-use Cosmetic red-light phototherapy system, home-use Cosmetic red-light phototherapy system, home-use Cosmetic red-light phototherapy system, home-use Cosmetic red-light phototherapy system, home-use Cosmetic red-light phototherapy system, home-use Cosmetic red-light phototherapy system, home-use Cosmetic red-light phototherapy system, home-use Cosmetic red-light phototherapy system, home-use Home-use intense pulsed light hair removal unit Home-use intense pulsed light hair removal unit Home-use intense pulsed light hair removal unit Home-use intense pulsed light hair removal unit Home-use intense pulsed light hair removal unit Home-use intense pulsed light hair removal unit Home-use intense pulsed light hair removal unit Home-use intense pulsed light hair removal unit Home-use intense pulsed light hair removal unit Home-use intense pulsed light hair removal unit Home-use intense pulsed light hair removal unit Home-use intense pulsed light hair removal unit Home-use intense pulsed light hair removal unit Home-use intense pulsed light hair removal unit Home-use intense pulsed light hair removal unit Home-use intense pulsed light hair removal unit Home-use intense pulsed light hair removal unit

• Primary Device ID: 05060352782837
• NIH Device Record Key: acf11b6a-e393-41eb-b5ac-a5e68099c99b
• Commercial Distribution Discontinuation: 2023-01-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMOOTHSKIN
• Version Model Number: SmoothSkin Pure
• Company DUNS: 424832900
• Company Name: CYDEN LIMITED
• 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: 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

Customer Support Contacts

• Phone: 1-800-715-9522
• Email: support-us@smoothskin.com
• Phone: 1-800-715-9522
• Email: support-us@smoothskin.com
• Phone: 1-800-715-9522
• Email: support-us@smoothskin.com
• Phone: 1-800-715-9522
• Email: support-us@smoothskin.com
• Phone: 1-800-715-9522
• Email: support-us@smoothskin.com
• Phone: 1-800-715-9522
• Email: support-us@smoothskin.com
• Phone: 1-800-715-9522
• Email: support-us@smoothskin.com
• Phone: 1-800-715-9522
• Email: support-us@smoothskin.com
• Phone: 1-800-715-9522
• Email: support-us@smoothskin.com
• Phone: 1-800-715-9522
• Email: support-us@smoothskin.com
• Phone: 1-800-715-9522
• Email: support-us@smoothskin.com
• Phone: 1-800-715-9522
• Email: support-us@smoothskin.com
• Phone: 1-800-715-9522
• Email: support-us@smoothskin.com
• Phone: 1-800-715-9522
• Email: support-us@smoothskin.com
• Phone: 1-800-715-9522
• Email: support-us@smoothskin.com
• Phone: 1-800-715-9522
• Email: support-us@smoothskin.com
• Phone: 1-800-715-9522
• Email: support-us@smoothskin.com
• Phone: 1-800-715-9522
• Email: support-us@smoothskin.com
• Phone: 1-800-715-9522
• Email: support-us@smoothskin.com
• Phone: 1-800-715-9522
• Email: support-us@smoothskin.com
• Phone: 1-800-715-9522
• Email: support-us@smoothskin.com
• Phone: 1-800-715-9522
• Email: support-us@smoothskin.com
• Phone: 1-800-715-9522
• Email: support-us@smoothskin.com
• Phone: 1-800-715-9522
• Email: support-us@smoothskin.com
• Phone: 1-800-715-9522
• Email: support-us@smoothskin.com
• Phone: 1-800-715-9522
• Email: support-us@smoothskin.com
• Phone: 1-800-715-9522
• Email: support-us@smoothskin.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060352782608 [Primary]
GS1	05060352782837 [Package]; Contains: 05060352782608; Package: box [6 Units]; Discontinued: 2023-01-01; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200184

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: 2020-06-30
• Device Publish Date: 2020-06-22

On-Brand Devices [SMOOTHSKIN]

• 05060352780550: Light Based Over-The-Counter Hair Removal
• 05060352780215: Light Based Over-The-Counter Hair Removal
• 05060352781151: Light Based Over-The-Counter Hair Removal
• 05060352782240: Light Based Over-The-Counter Hair Removal
• 05060352782837: Light based Over-The-Counter Hair Removal
• 05060352783643: Light Based Over-The-Counter Hair Removal
• 05060352784084: Light Based Over-The-Counter Hair Removal
• 05060352784091: Light Based Over-The-Counter Hair Removal
• 05060352783551: Light Based Over-The-Counter Hair Removal
• 05060352783544: Light based Over-The-Counter Hair Removal
• 05060352784176: Light Based Over-The-Counter Hair Removal
• 05060352784145: Light Based Over-The-Counter Hair Removal
• 05060352784329: Light Based Over-The-Counter Hair Removal
• 05060352785586: Light based Over-The-Counter Hair Removal
• 05060352785562: Light based Over-The-Counter Hair Removal