PinPointe FootLaser

GUDID 00108690800002

Short Pulsed Nd:YAG Laser

NUVOLASE INC.

Dermatological solid-state laser system

• Primary Device ID: 00108690800002
• NIH Device Record Key: 63060573-7f21-442b-9c62-b74fb9d1537b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PinPointe FootLaser
• Version Model Number: PinPointe FootLaser
• Company DUNS: 078274442
• Company Name: NUVOLASE INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does n
• 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	00108690800002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093547

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-31

On-Brand Devices [PinPointe FootLaser]

• 00108690800002: Short Pulsed Nd:YAG Laser
• 00869080000207: Short pulsed Nd:YAG laser