The Helios II® laser system is based on the Nd:YAG (1064 nm) and frequency doubled KTP Nd:YAG (532 nm) laser technology. Three basic elements of operations are as follows:

A Nd:YAG crystal is used as a gain medium which produces a laser beam.
A resonator then amplifies the beam.
A lamp that contains Xe gas is used, as a pumping light source. The lamp requires a high-pressure power source device for operation. When the electric energy generated from the high-pressure power source is induced into the electrode of the lamp, it converts into light energy. This converted light energy pumps the Nd:YAG crystal - a gain medium - and the light exhausted from the crystal is amplified into a specific wavelength light. As it passes between the resonant gases, laser beam radiates to an output unit.

The regulation of laser output and repetition rate can be set by the user via GUI (Graphic User Interface) and controlled by microprocessor, which interfaces with the power supply.

AI/ML Overview

The provided text is a 510(k) summary for the Helios II® Q-Switched Nd:YAG Laser System. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study proving the device meets specific acceptance criteria through performance data.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, and MRMC studies are not available in the provided document.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria with corresponding device performance metrics. Instead, it states that the device "share very similar / exactly same performance specification parameters" as its predicate devices, implying that the performance of the predicate devices implicitly sets the "acceptance criteria."

Acceptance Criteria (Implied from Predicate Equivalence)	Reported Device Performance
Performance specifications of Fotona QX Nd:VAG/KTP Laser System (K053139)	"very similar / exactly same performance specification parameters" to predicate devices
Performance specifications of Medlite C3 Q Switched Nd:YAG Laser (K011677)	"very similar / exactly same performance specification parameters" to predicate devices
Performance specifications of Medlite C6 Q Switched Nd:YAG Laser (K014234)	"very similar / exactly same performance specification parameters" to predicate devices

2. Sample Size Used for the Test Set and Data Provenance:

Sample size for the test set: Not provided. The document does not describe a specific "test set" in the context of performance evaluation with discrete metrics.
Data Provenance: Not applicable, as no specific performance study with a test set is described.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. No ground truth establishment for a test set is described.

4. Adjudication Method for the Test Set:

Not applicable. No adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The document states "None" under "Performance Data" except for the conclusion about substantial equivalence. This type of study would involve human readers and AI performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a laser system, not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance data section doesn't detail any standalone performance tests for the laser beyond the claim of substantial equivalence.

7. The Type of Ground Truth Used:

Not applicable. No ground truth is described in the context of a performance study. The approval is based on substantial equivalence to predicate devices, which implies that the predicate devices' established safety and effectiveness serve as the "ground truth" for demonstrating equivalence.

8. The Sample Size for the Training Set:

Not applicable. This device is a laser system, not an AI algorithm or a device requiring a "training set" in the typical sense of machine learning.

9. How the Ground Truth for the Training Set was Established:

Not applicable for the same reasons as above.

Summary

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510(K) Summary - K083203

Applicant:	Laseroptek Co. Ltd.
Address:	204 Hyundai I Valley223-12 Sangdaiwon, JungwonSungnam, Kyunggi 462-714South Korea
Contact Person:	Dr. Hong Chu (President)
Telephone / Fax / E-mail:	Tel) 82.31.737.9885~8Fax) 82.31.737.9889E-mail) hchu@laseroptek.com
Submitter:	DPS International
Address:	22750 Hawthorne Blvd., Suite 211Torrance, CA 90505
Contact Person:	Kevin J. Choi
Telephone / Fax / E-Mail:	Tel) 310.634.4480Fax) 310.378.8186E-mail) kjchoil 128@hotmail.com
Preparation Date:	August 16, 2008
Device Trade Name:	Helios II® Q-Switched Nd:YAG Laser System
Common Name:	Nd:YAG Pulsed Surgical Laser
Classification Name:	Instrument, Surgical, Powered laser, 79-GEX, 21CFR 878-4810

Helios II® Q-Switched Nd:YAG Laser System

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Los 3203 p-2

Helios II® Q-Switched Nd:YAG Laser System

Legally Marketed Predicate Devices:	Fotona QX Nd:VAG/KTP Laser System,K053139, by Fotona d.d.Medlite C3 Q Switched Nd:YAG Laser,K011677, by Continuum Electro-Optics, Inc(now Hoya CouiBio, Inc)Medlite C6 Q Switched Nd:YAG Laser,K014234, by Continuum Electro-Optics, Inc(now Hoya CouiBio, Inc)
Description of the Helios II® Q-Switched Nd:YAG Laser System:	The Helios II® laser system is based on the Nd:YAG(1064 nm) and frequency doubled KTP Nd:YAG(532 nm) laser technology. Three basic elements ofoperations are as follows:1) A Nd:YAG crystal is used as a gain mediumwhich produces a laser beam.2) A resonator then amplifies the beam.3) A lamp that contains Xe gas is used, as apumping light source. The lamp requires ahigh-pressure power source device foroperation. When the electric energygenerated from the high-pressure powersource is induced into the electrode of thelamp, it converts into light energy. Thisconverted light energy pumps the Nd:YAGcrystal - a gain medium - and the lightexhausted from the crystal is amplified into aspecific wavelength light. As it passesbetween the resonant gases, laser beamradiates to an output unit.

Legally Marketed Predicate Devices:

Fotona QX Nd:VAG/KTP Laser System,K053139, by Fotona d.d.Medlite C3 Q Switched Nd:YAG Laser,K011677, by Continuum Electro-Optics, Inc(now Hoya CouiBio, Inc)Medlite C6 Q Switched Nd:YAG Laser,K014234, by Continuum Electro-Optics, Inc(now Hoya CouiBio, Inc)

Description of the Helios II® Q-Switched Nd:YAG Laser System:

The Helios II® laser system is based on the Nd:YAG(1064 nm) and frequency doubled KTP Nd:YAG(532 nm) laser technology. Three basic elements ofoperations are as follows:1) A Nd:YAG crystal is used as a gain mediumwhich produces a laser beam.2) A resonator then amplifies the beam.3) A lamp that contains Xe gas is used, as apumping light source. The lamp requires ahigh-pressure power source device foroperation. When the electric energygenerated from the high-pressure powersource is induced into the electrode of thelamp, it converts into light energy. Thisconverted light energy pumps the Nd:YAGcrystal - a gain medium - and the lightexhausted from the crystal is amplified into aspecific wavelength light. As it passesbetween the resonant gases, laser beamradiates to an output unit.

The regulation of laser output and repetition rate can be set by the user via GUI (Graphic User Interface) and controlled by microprocessor, which interfaces with the power supply.

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510(K) Summary - K083203

Helios II® Q-Switched Nd:YAG Laser System

Intended Use of the Helios II® Q-Switched Nd:YAG Laser System:

The Helios II® Q-Switched Nd:YAG Laser System delivers continuous wave laser light in the contact or non-contact mode for;

· Tattoo Removal

dark ink: blue and black
· light ink: red
light ink: sky blue
· light ink: green

Treatment of Vascular Lesions:

port wine birthmarks
· telangiectasias
· spider angioma
· cherry angioma
· spider nevi

Treatment of Pigmented Lesions:

· café-au-lait birthmarks
· solar lentiginos
· senile lentiginos
· becker's nevi
freckles
nevus spilus
· nevus of ota

None

Performance Data:

Conclusion:

The Helios II® Q-Switched Nd:YAG Laser System is substantially equivalent to other existing systems in commercial distribution for treatment of the intended use indication as listed above and share very similar / exactly same performance specification parameters.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 8 2009

Laseroptek Co. Ltd. % DPS International Mr. Kevin J. Choi 22750 Hawthorne Boulevard #211 Torrance, California 90505

Received: April 22, 2009

Re: K083203

Trade/Device Name: Helios II Q-Switched ND: YAG Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: April 20, 2009

Dear Mr. Choi:

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

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Page 2 - Mr. Kevin J. Choi

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. N. elkerson Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K083203 p. lot 1

Indications for Use

510(k) Number (if known):

K083203

Device Name:

Helios II Q-Switched ND:YAG Laser System

Indications For Use:

Incision, excision, ablation, vaporization of soft tissue for general dermatology.

Removal or lightening of unwanted hair with or without adjuvant preparation.

Tattoo Removal

dark ink: blue and black .
light ink. red
light ink: sky blue
light ink: green

Treatment of Vascular Lesions:

port wine birthmarks
telangiectasias .
spider angioma
cherry angioma .
spider nevi

Treatment of Pigmented Lesions:

café-au-lait birthmarks .
solar lentiginos .
senile lentiginos .
becker's nevi
freckles
nevus spilus
nevus of ota

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

AND/OR

age 1 of 1

(Division Sign-Off) Division of General, Restorative. and Neurological Devices

510(k) Number K083203

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.