STETIC SENSE

GUDID 16970821120052

Stetic Medical Aesthetics Development (Shenzhen)Co.,Ltd.

Cosmetic red-light phototherapy system, home-use

• Primary Device ID: 16970821120052
• NIH Device Record Key: 83b02e75-e11b-499d-8c69-f2a5b55bb8a0
• Commercial Distribution Discontinuation: 2019-12-22
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: STETIC SENSE
• Version Model Number: IPL-HQ3HU-SP
• Company DUNS: 544464442
• Company Name: Stetic Medical Aesthetics Development (Shenzhen)Co.,Ltd.
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970821120055 [Primary]
GS1	16970821120052 [Package]; Contains: 06970821120055; Package: [4 Units]; Discontinued: 2019-12-22; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161565

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-02-24
• Device Publish Date: 2018-12-22

On-Brand Devices [STETIC SENSE]

• 16970821120052: IPL-HQ3HU-SP
• 16970821120045: IPL-HG1HU-SP
• 06970821120017: IPL-380-IT