Diode Laser Hair Removal

Basic Information

• Brand Name: Diode Laser Hair Removal
• Primary DI: 06940481500221
• Version / Model: LHR-V6S/B-1064
• Company Name: Wuhan Lotuxs Technology Co.,Ltd.
• Labeler DUNS: 421343727
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-29
• Public Version: 1
• Public Version Date: 2024-09-06
• Public Version Status: New
• Public Device Record Key: 51a6aa40-d0d5-4344-858b-88b6df71969d

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OHT	Light Based Over-The-Counter Hair Removal	General, Plastic Surgery	878.4810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
67091	Home-use laser epilator	An electrically-powered device intended to be used in the home by a layperson to remove unwanted body hair using low-level laser energy applied to the hair roots of the target skin area. It consists of a hand-held piece with an integrated diode laser, controls, and a distal end designed to be held on the skin site during treatment; some types have a built-in camera for detecting the position of hair follicles to assist precise focusing of the laser pulse.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06940481500221	GS1

Premarket Submissions

Submission Number	Supplement Number
K232117	000