LightScalpel

Basic Information

• Brand Name: LightScalpel
• Primary DI: 00851842007074
• Version / Model: H-A110
• Catalog Number: LS9002-02
• Company Name: Lightscalpel, LLC
• Labeler DUNS: 033516010
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2018-09-24
• Public Version Status: Update
• Public Device Record Key: f169d537-fb8f-45a7-a9f6-dc9f89222373

Device Description

Angled Handpiece, Tapered

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	878.4810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36184	Laser adaptor	A connecting device, usually a small part, designed to join a device or component to a laser, or join devices being used with the laser, or to make any of these devices compatible so that they mate together (e.g., a laser contact probe from one manufacturer connect to the laser delivery arm of a laser from a different manufacturer). Included are optical couplers designed to connect a laser source to a fibreoptic laser delivery system. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851842007074	GS1
Direct Marking	00851842007470	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K141658	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Straight

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 40 – 70 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius