JOULE 1500-XXX-XX

GUDID 00863249000305

Multi-platform laser/light device for medical use.

SCITON, INC.

Multi-modality skin surface treatment system

• Primary Device ID: 00863249000305
• NIH Device Record Key: 06572df5-f5fb-40f9-87e4-fd462c0657ef
• Commercial Distribution Discontinuation: 2038-02-11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JOULE
• Version Model Number: JOULE
• Catalog Number: 1500-XXX-XX
• Company DUNS: 015831290
• Company Name: SCITON, INC.
• 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

Customer Support Contacts

• Phone: 650-493-9155
• Email: service@sciton.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863249000305 [Primary]

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2018-02-12

Devices Manufactured by SCITON, INC.

• 00863249000329 - mJoule: 2020-07-17 Multi-platform laser/light device for medical use.
• 00863249000305 - JOULE: 2018-03-29Multi-platform laser/light device for medical use.
• 00863249000305 - JOULE: 2018-03-29 Multi-platform laser/light device for medical use.
• 00863249000312 - BBLs: 2018-03-29 Intense pulsed light medical device