Ergoline/AFFINITY 700 Advanced Performance, Soltron L-70 BUTTERFLY

GUDID EJKP100003617A0

JK-Products GmbH

Ultraviolet tanning device

• Primary Device ID: EJKP100003617A0
• NIH Device Record Key: 9c970b6a-f658-4cc0-b51d-9c0278ee711c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ergoline/AFFINITY 700 Advanced Performance, Soltron L-70 BUTTERFLY
• Version Model Number: JK 155 / 46-3 AC
• Company DUNS: 316232073
• Company Name: JK-Products GmbH
• 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
HIBCC	EJKP100003617A0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151400

FDA Product Code

• LEJ: Booth, Sun Tan

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: 2019-04-12
• Device Publish Date: 2019-04-04

On-Brand Devices [Ergoline/AFFINITY 700 Advanced Performance, Soltron L-70 BUTTERFLY]

• EJKP100003617A0: JK 155 / 46-3 AC
• EJKP100003271A0: JK 155 / 46-3
• EJKP100003267A0: JK 155 / 46-3 AC