E>EYE C

GUDID 03662824000207

E-SWIN

Light-energy skin surface treatment system applicator Light-energy skin surface treatment system applicator Light-energy skin surface treatment system applicator Light-energy skin surface treatment system applicator Light-energy skin surface treatment system applicator Light-energy skin surface treatment system applicator Light-energy skin surface treatment system applicator Light-energy skin surface treatment system applicator Light-energy skin surface treatment system applicator Light-energy skin surface treatment system applicator Light-energy skin surface treatment system applicator Light-energy skin surface treatment system applicator Light-energy skin surface treatment system applicator Light-energy skin surface treatment system applicator Light-energy skin surface treatment system applicator Light-energy skin surface treatment system applicator

• Primary Device ID: 03662824000207
• NIH Device Record Key: 146439cc-8b5f-43c2-aa9d-17b3df440e60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E>EYE C
• Version Model Number: D029AF001C08A
• Company DUNS: 267700713
• Company Name: E-SWIN
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03662824000207 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200616

FDA Product Code

• GEX: Powered Laser Surgical Instrument

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: 2022-04-12
• Device Publish Date: 2022-04-04

Devices Manufactured by E-SWIN

• 03662824001846 - TearCheck T: 2023-03-14
• 03662824003048 - TearCheck T: 2023-03-14
• 03662824000207 - E>EYE C: 2022-04-12
• 03662824000207 - E>EYE C: 2022-04-12