TheraClear

GUDID M709THCLR01

Intense Pulsed Light Skin Surface Treatment System

Strata Skin Sciences, Inc.

Intense pulsed light skin surface treatment system

• Primary Device ID: M709THCLR01
• NIH Device Record Key: 912022d2-0281-47da-9502-0fc452c534b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TheraClear
• Version Model Number: TC40
• Company DUNS: 618522536
• Company Name: Strata Skin Sciences, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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
HIBCC	M709THCLR01 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101415

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: 2025-03-14
• Device Publish Date: 2025-03-06

Devices Manufactured by Strata Skin Sciences, Inc.

• M709THCLR01 - TheraClear: 2025-03-14Intense Pulsed Light Skin Surface Treatment System
• M709THCLR01 - TheraClear: 2025-03-14 Intense Pulsed Light Skin Surface Treatment System
• M709AL100000 - XTRAC: 2024-05-22 Excimer Laser
• 010822602 - XTRAC: 2021-03-10
• 010822603 - XTRAC: 2021-03-10
• 00408919 - VTRAC: 2018-12-21
• 00408939 - VTRAC: 2018-12-21