LightScalpel LS9007-01

GUDID 00851842007029

1.75m, CO2 Laser Waveguide

Lightscalpel, LLC

Laser adaptor

• Primary Device ID: 00851842007029
• NIH Device Record Key: 129fac9a-8b82-446b-88a9-ba249ce50645
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LightScalpel
• Version Model Number: LSF-175
• Catalog Number: LS9007-01
• Company DUNS: 033516010
• Company Name: Lightscalpel, LLC
• 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: 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

Customer Support Contacts

• Phone: 1-866-697-7548
• Email: info@lightscalpel.com

Device Dimensions

• Length: 1.75 Meter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851842007029 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123037

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: 2016-09-24

On-Brand Devices [LightScalpel]

• 00851842007531: Focused, Compact Backstop Handpiece
• 00851842007425: Tip, 0.25mm Spot, Thinwall, Non-Sterile
• 00851842007418: Tip, 0.8mm Spot, Short, Non-Sterile
• 00851842007401: Tip, 0.25mm Spot, Non-Sterile
• 00851842007395: Tip, 0.4mm Spot, Non-Sterile
• 00851842007388: Tip, 0.8mm Spot, Non-Sterile
• 00851842007357: Tip, 0.25mm Spot, Thinwall, Sterile, 5 Pack
• 00851842007333: Fiber End Protector
• 00851842007326: Cord Retainer - 2 Pack
• 00851842007319: Accessory Tray
• 00851842007302: Mirror, Angled, Tipped Handpiece
• 10851842007296: Tip, 1.4mm Spot, Sterile, Single
• 10851842007289: Tip, 0.25mm Spot, Thinwall, Sterile, Single
• 00851842007272: Tip, 0.8mm Spot, Short, Sterile, 5 Pack
• 00851842007258: Tip, 0.25mm Spot, Sterile, 5 Pack
• 00851842007234: Tip, 0.4mm Spot, Sterile, 5 Pack
• 00851842007210: Tip, 0.8mm Spot, Sterile, 5 Pack
• 00851842007197: LS-2010, 20W CO2 Laser System
• 00851842007180: LS-1005, 10W CO2 Laser System
• 00851842007173: Mirror, Gold, Focused Handpiece
• 00851842007166: Accessory Brush, LS Handpieces
• 00851842007159: LS Adapter, Tip Retainer
• 00851842007142: LS Adapter, Focusing Lens
• 00851842007135: Holster, LS Accessories
• 00851842007128: Accessory Tool, LS Handpieces
• 00851842007111: Adjustable Focused Handpiece
• 00851842007104: Angled, Tipped Handpiece
• 00851842007098: Straight, Tipped Handpiece
• 00851842007081: Straight Handpiece, Tapered
• 00851842007074: Angled Handpiece, Tapered
• 00851842007067: Focused, Angled, Handpiece, 0.25mm Spot
• 00851842007050: Focused, Straight, Handpiece, 0.8mm Spot
• 00851842007043: Focused, Straight, Handpiece, 0.4mm Spot
• 00851842007036: Focused, Straight, Handpiece, 0.25mm Spot
• 00851842007029: 1.75m, CO2 Laser Waveguide
• 00851842007012: Waveguide, CO2, Medical 1.5 Meter
• 00851842007005: Waveguide, CO2, Medical 1.0 Meter
• 00851842007555: Focused, Angled Compact Backstop Handpiece
• 00851842007296: Tip, 1.4mm Spot, Sterile, Single
• 00851842007289: Tip, 0.25mm Spot, Thinwall, Sterile, Single
• 00851842007593: Large Spot Tip-Lock Handpiece
• 00851842007579: Tip, 3.2mm Large Spot, Non-Sterile
• 00851842007562: Tip, 2.6mm Large Spot, Non-Sterile
• 00851842007616: Focused, Hybrid Compact Backstop Handpiece
• 00851842007647: Focused, Standard Backstop Handpiece
• 00851842007654: Large Spot Tip-Lock Long Barrel Handpiece
• 00851842007661: 5-Pack, Tip, 2.5mm Large Spot Size, Non-Sterile
• 00851842007623: LS-4020, 40W CO2 Laser System
• 00851842007685: Extra-Large Spot Handpiece