LUMIX C.P.S.

Basic Information

• Brand Name: LUMIX C.P.S.
• Primary DI: 08057949170099
• Version / Model: LUMIX C.P.S.1
• Catalog Number: LCPS702
• Company Name: FISIOLINE SRL
• Labeler DUNS: 338384498
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 48571074-41ab-43bf-ae61-25c4f13e9193

Device Description

LASER THERAPY UNIT LUMIX C.P.S. with 3 WAVELENGTH (650nm+810nm+910nm)

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	890.5500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36775	Skin laser scanner	An electromechanical device intended to enable a laser beam, produced by an appropriate laser, to be scanned uniformly over a broad field of skin, typically for the removal of skin lesions (e.g., birthmarks, pigmentations) and tattoos. A laser beam is typically so intensely focused that only a tiny area can be treated at a time; large areas of skin must be treated using a scanner which sweeps the beam back and forth over the total target area.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08057949170099	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K160947	000

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	910	Nanometer
Lumen/Inner Diameter	810	Nanometer
Lumen/Inner Diameter	650	Nanometer
Lumen/Inner Diameter	10	Millimeter

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 45 – 60 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 40 – 60 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 5 – 45 Degrees Celsius