S-430

Basic Information

• Brand Name: S-430
• Primary DI: 07290016681352
• Version / Model: FS90011
• Catalog Number: FS90011
• Company Name: FORMATK SYSTEMS LTD
• Labeler DUNS: 532396673
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-16
• Public Version: 1
• Public Version Date: 2019-01-16
• Public Version Status: New
• Public Device Record Key: 69d84312-0eba-42ab-8b58-dca13b3ee32b

Device Description

IPL (Intense Pulsed Light) Applicator to be used with Formatk Systems Ltd supporting systems for the treatment of Acne

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: 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
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	General, Plastic Surgery	878.4810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45222	Light-energy skin surface treatment system applicator	A handpiece that is part of a skin surface treatment system that conducts one or more generated light energies [e.g., fluorescent, ultraviolet B (UVB)] used for ablative and non-ablative treatment of skin conditions (e.g., acne, psoriasis, vascular lesions, wrinkles, large pores). This device is connected to a generator and is applied by the practitioner or staff directly to the area to be treated. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290016681352	GS1

Premarket Submissions

Submission Number	Supplement Number
K183307	000