It is indicated for incision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology(ENT), gynaecology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

Device Description

The Jeisys EdgeOne CO2 Laser is comprised of the following major components:

The main console unit
Delivery handpieces (2 surgical and one fractional)
Footswitch.
Accessories

AI/ML Overview

This document is a 510(k) premarket notification for the Jeisys EdgeOne CO2 Laser and does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device.

The document details the device's substantial equivalence to predicate devices based on:

Indications for Use: The Jeisys EdgeOne CO2 Laser is indicated for incision, ablation, vaporization, and coagulation of body soft tissues in various medical specialties, and for ablative skin resurfacing with a scanning unit. Its indications are identical to the secondary predicate (K133895) and largely overlap with the primary predicate (K100590).
Technical Characteristics: A table compares the Jeisys EdgeOne CO2 Laser's technical specifications (e.g., laser type, wavelength, output power, pulse duration, scan area, spot size, operational modes) to those of the predicate devices. The specifications are largely identical to the primary predicate and comparable to the secondary predicate.
Safety and Effectiveness Information: The document states that the device's compliance with several IEC standards (IEC 60601-1, IEC 60601-2-22, IEC 60601-1-2) demonstrates its safety.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance as none of that information is present in the provided text. The document focuses solely on establishing substantial equivalence to legally marketed predicate devices for a conventional medical device (a CO2 laser), not an AI/ML-driven one.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 27, 2016

Jeisys Medical Inc. % Kathy Maynor Consultant Ronyam Enterprises LLC 26 Rebecca Ct Homosassa, Florida 34446

Re: K162169

Trade/Device Name: EdgeOne CO2 Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX. ONG Dated: July 30, 2016 Received: August 3, 2016

Dear Ms. Maynor:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely, Jennifer R. Stevenson -A For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director

Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162169

Device Name Jeisys EdgeOne CO2 Laser

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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I. General Information

Submitter:	JEISYS MEDICAL INC.307 Daeryung Techno Town 8th481-11, Gasan-Dong, Geumcheon-GuSeoul Seoul Teugbyeolsi, KOREA, REPUBLICOF 153-775
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Contact Person:	Kathy Maynor
	Consultant
	352-586-3113 (cell)
Summary Preparation Date:	July 29, 2016

II. Names

Device Names:	The Jeisys EdgeOne CO2 Laser
Primary Classification Names:	Surgical Powered Light Instrument,

III. Predicate Devices

K #	Predicate Device
K100590	EDGE CO2 LASER SYSTEM
K133895	DEKA SMARTXIDE LASER SYSTEM

IV. Product Description

The Jeisys EdgeOne CO2 Laser is comprised of the following major components:

1. The main console unit
1. Delivery handpieces (2 surgical and one fractional)
1. Footswitch.
Accessories 4.

V. Indications for Use

It is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology(ENT), gynaecology, neurosurgery, orthopaedics, general and thorasic surgery

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(including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

VI. Summary of Technical Characteristics

Parameter	K16XXXJeisys Edge One Laser	K100590Jeisys Edge One Laser(Predicate Device)	K133895Deka Smartxide 2(Secondary Predicate)
Product Code &Regulation No.	GEX, ONG21 CFR 878.4810	GEX21 CFR 878.4810	GEX21 CFR 878.4810
Laser Type	CO2	CO2	CO2
Laser wavelength	10.6µm	10.6µm	10.6µm
Output power	30W	30W	60W
Pulse Duration	1-1000ms	1-1000ms	100 ~2,000 µs
Fractional Pulseenergy	1-300mJ	1-300mJ	Unknown
Repetition rate	10-500Hz	10-500Hz	5Hz to 100Hz
Scan area	15 x 15mm2	15 x 15mm2	15 x 15mm
Spot size (fractional)	120um, 350um, 800um	120um, 350um, 800um	125µm, 155µm, 267µm,325μm, 489µm, 530μm
Surgical handpieces	0,15, 1	NA	0.15, 1, collimated,dental
Operational mode	Fractional mode, normalmode (CW, Pulse, SinglePulse, Repeat, Grouppulse, Ultra)	Fractional mode, normalmode (CW, Pulse, SinglePulse, Repeat, Grouppulse, Ultra)	Fractional CW, SP, DP,HP, UPNormalInterlacedSmartTrack
Aiming beam	Diode laser(Red) 655 +/-10nm, Max 1mW	Diode laser(Red) 655 +/-10nm, Max 1mW	Diode laser (Red) 635nm,4mW max
Fractional	Spot density 0-42.4%	Spot density 0-42.4%	Unknown
Cooling	Water	Water	Water
User Interface	LCD touch screen	LCD touch screen	LCD touch screen
Optical guide	Articulated arm	Articulated arm	Articulated arm
ElectricalRequirements	230V~, 50/60Hz,500VA(max. laseroutput), 100 VA(stand-by)	230V~, 50/60Hz,500VA(max. laseroutput), 100 VA(stand-by)	100-120V~/220-230V~,50/60Hz, 1600VA
Indications for Use	It is indicated forincision, excision,ablation, vaporization andcoagulation of body softtissues in medicalspecialties includingaesthetic (dermatologyand plastic surgery),podiatry,otolaryngology(ENT),gynaecology,neurosurgery,orthopaedics, general andthoracic surgery(including open andendoscopic), dental andoral surgery andgenitourinary surgery.The use with the scanningunit is indicated forablative skin resurfacing.	The Edge CO 2 laserwhen used in traditionalnon-fractionated scannermode isindicated for incision,excision, ablation,vaporization, andcoagulation of body softtissues.The Edge CO 2 laserwhen used infractionated mode isindicated for ablativeskinresurfacing.	It is indicated forincision, excision,ablation, vaporizationand coagulation of bodysoft tissues in medicalspecialties includingaesthetic (dermatologyand plastic surgery),podiatry,otolaryngology(ENT),gynaecology,neurosurgery,orthopaedics, generaland thoracic surgery(including open andendoscopic), dental andoral surgery andgenitourinary surgery.The use with thescanning unit is indicatedfor ablative skinresurfacing.

Table 1: Salient Characteristics of the Jeisys EdgeOne CO2 Laser and the Predicate Devices

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VII. Safety and Effectiveness Information

The review of the indications for use and technical characteristics provided demonstrates that the Jeisys EdgeOne CO2 laser is substantially equivalent to the predicate devices.

Product testing performed included:

IEC 60601-1:2005 + CORR.1 (2006) + CORR.2 (2007) Medical electrical equipment – General Requirements for Electrical Safety - NO DEVIATIONS

IEC 60601-2-22:2007 (Third Edition) + A1 (2012) for use with IEC 60601-1:2005 + A1 (2012) Medical Electrical Equipment - Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

IEC60601-1-2:2007 - Section 6, not life-supporting equipment, group 1&2, Class A - Medical Electrical Equipment PART 1: GENERAL REQUIREMENTS FOR SAFETY 2. COLLATERAL STANDARD: ELECTROMAGNETIC COMPATIBILITY - REQUIREMENTS AND TESTS

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VIII. Conclusion

The Jeisys EdgeOne CO2 laser was found to be substantially equivalent to the predicate devices.

The Jeisys EdgeOne CO2 laser shares the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.