QMODE

GUDID 08800209800027

SPECLIPSE, Inc.

Multi-modality skin surface treatment system generator

• Primary Device ID: 08800209800027
• NIH Device Record Key: ebe48606-8af5-4d87-8226-70a8f25fed7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QMODE
• Version Model Number: 01
• Company DUNS: 694509874
• Company Name: SPECLIPSE, 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: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800209800027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K253344

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: 2026-01-14
• Device Publish Date: 2026-01-06

Devices Manufactured by SPECLIPSE, Inc.

• 08800209800003 - PICO-K: 2026-01-19
• 08800209800034 - PICOFY: 2026-01-19
• 08800209800010 - BELLUS-Q: 2026-01-14
• 08800209800027 - QMODE: 2026-01-14
• 08800209800027 - QMODE: 2026-01-14