The diode laser is a surgical device intended for use in dermatologic and general surgical procedure. It utilizes a semiconductor diode with invisible infrared radiation as a laser source (808 nm). The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a footswitch.

The diode laser emits 808nm wavelength laser which is absorbed by melanin and at the same time greatly reduce the absorption by water and haematoglobin. The laser beam penetrates through epidermis into dermis and absorbed by melanin in hair and hair follicle, producing laser photothermal effect, conducting the energy from hair section to hair toot, rising temperature of melanin and decomposing it, thus reaching effect of hair removal.

During treatment, the Sapphire in handpiece assures reliable and constant cooling result for skin surface with the maximum comfort and safety. When the laser system starts to release energy, skin cooling system works automatically. The cooling system reduces the temperature of treatment area and increase treatment comfort.

The proposed device includes power supply system, central control system, cooling system, laser deliver system and safety feature.

The cover material of the proposed device is ABS (Acrylonitrile Butadiene Styrene) plastic. The patient contact components in laser handpiece include supporting plate which is made of stainless steel and crystal which is made of sapphire.

AI/ML Overview

The provided document describes a 510(k) submission for a Diode Laser (model DLH-06) intended for dermatologic and general surgical procedures, specifically hair removal and permanent hair reduction.

Here's an analysis of the provided information concerning acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" for the device's clinical efficacy (e.g., specific percentage of hair reduction deemed acceptable). Instead, it relies on demonstrating substantial equivalence to a predicate device. The performance is assessed through bench tests to meet design specifications and compliance with relevant standards.

However, we can infer some "performance characteristics" from the device specifications and the comparison to the predicate device.

Characteristic	Acceptance Criteria (Implied by Predicate/Standards)	Reported Device Performance (Diode Laser DLH-06)
Safety	Compliance with IEC 60601-1-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2	Complies with all listed safety standards (IEC 60601-1-1:1988+A1:1991+A2:1995, IEC 60601-2-22: 1995, IEC 60825-1: 2007, IEC 60601-1-2:2007)
Biocompatibility	Compliance with ISO 10993-5, ISO 10993-10	Complies with ISO 10993-5:2009, ISO 10993-10:2002/Amd. 1: 2006
Wavelength	Comparable to predicate (810 nm)	808 nm (considered similar, 2nm difference not raising new safety/effectiveness issues)
Fluence (FHR)	≤ 10 J/cm² (predicate's SHR Mode)	≤ 10 J/cm² (FHR Mode)
Fluence (Standard)	≤ 120 J/cm² (predicate's HR Mode)	≤ 120 J/cm² (Standard Mode)
Repetition Rate (FHR)	≤ 10 Hz (predicate's SHR Mode)	≤ 10 Hz (FHR Mode)
Repetition Rate (Standard)	≤ 3 Hz (predicate's HR Mode)	≤ 3 Hz (Standard Mode)
Pulse Width (FHR)	≤ 20 ms (predicate's SHR Mode)	≤ 20 ms (FHR Mode)
Pulse Width (Standard)	5-200 ms (predicate's HR Mode)	5-200 ms (Standard Mode)
Energy Measurement Stability	Not explicitly stated as "acceptance criteria", but tested for minimal deviation.	-0.03% per working time (Energy measurement comparison between plan to use and leave the factory)
Cumulative Measurement Uncertainty	Not explicitly stated as "acceptance criteria", but reported.	U=2%(k=2)

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

The document describes bench tests to verify design specifications and compliance with standards. It does not describe a clinical study with a "test set" of patients. Therefore, information on sample size for a test set, country of origin, or retrospective/prospective nature of a clinical study is not available in this document. The data provenance is from laboratory/engineering bench tests.

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

Since no clinical study with a patient "test set" is described, there is no information regarding experts used for establishing ground truth or their qualifications. The "ground truth" here is defined by the technical specifications and adherence to international safety and performance standards for laser devices.

4. Adjudication Method for the Test Set

As no clinical study or test set involving human subjects is described, there is no information on an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned or implied. The focus of this submission is on demonstrating substantial equivalence through technical specifications and compliance with standards, not on comparing human reader performance with and without AI assistance. This device is a laser system, not an AI-assisted diagnostic tool.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

This concept is not applicable to the device described. The device is a laser system, not an algorithm, and its operation involves a human operator. The document describes bench tests of the device itself.

7. Type of Ground Truth Used

The "ground truth" for this submission is based on:

Engineering Specifications: The design parameters of the device (wavelength, fluence, spot size, etc.).
International Standards: Compliance with recognized safety and performance standards for medical electrical equipment and laser products (e.g., IEC 60601 series, IEC 60825-1, ISO 10993 series).
Predicate Device Characteristics: The established safety and effectiveness characteristics of the legally marketed predicate device (Alma Lasers Modified Diode Laser Module with SHR Treatment Mode). Substantial equivalence is the primary ground for approval.

8. Sample Size for the Training Set

Since no clinical study (and thus no "training set" of patient data for an algorithm) is described, there is no information on the sample size for a training set.

9. How the Ground Truth for the Training Set Was Established

As there is no training set mentioned in the context of an algorithm or clinical study, this information is not applicable. The "ground truth" for the device's development and testing involved adherence to technical specifications, manufacturing standards, and regulatory requirements, as assessed through bench testing and comparison to a predicate device.

Summary

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APR 2 1 2013

Exhibit #4 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) Number: K123483

Date of Submission: Nov 10, 2012
Sponsor

・

Beijing Syntech Laser Co., Ltd 5F, No.1 Building, No.65 Jiancaicheng West Road, Xisanqi, Haidian District, Beijing, 100096, P.R. China Establishment Registration Number: 3007535734 Contact Person: Jianghua Jin Position: Vice General Manager Tel: +86-10-82939866 Fax: +86-10-82935528 Email: Jeff@syntechlaser.com

Submission Correspondent

Ms. Diana Hong & Mr. Tarzan Wang Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net

Proposed Device Identification 4.

Proposed Device Trade Name: Diode Laser Proposed Device Model: DLH-06 Proposed Device Common Name: Laser System Proposed Device Classification name: Powered Laser Surgical Instrument Classification: II

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દ્વારા :

Product Code: GEX

Regulation Number: 21 CFR 878.4810

Review Panel: General& Plastic Surgery

Intended Use Statement:

The Diode Laser is intended for use in dermatologic and general surgical procedures.

The Standard Mode is intended for hair removal, permanent hair reduction.

The FHR Mode is intended for hair removal, permanent hair reduction.

The diode laser system is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.

Predicate Device Identification

510(k) Number: K112031

Product Name: Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for use with the Family of Soprano XL Multi-Application Platforms.

Manufacturer: Alma Lasers, Inc.

6. Device Description

The proposed device includes power supply system, central control system, cooling system, laser deliver system and safety feature.

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crystal which is made of sapphire.

Item	Specification
Light type	Diode laser
Wavelength (nm)	808
Fluence (J/cm²) max	≤10 (FHR)
	≤120 (Standard)
Beam divergence (mard)	10 (short side),40 (long side)
Spot Size (mm)	12 X 10
Pulse width (ms)	≤20 ms(FHR)
	5-200 ms (Standard)
Repetition rate (Hz)	≤10 Hz(FHR)
	≤3 Hz(Standard)
Skin cooling	Contact cooling
Dimensions (D X W X H,mm)	460 X 365 X 350
Weight (kg)	26 kg
The energy measurement comparisonbetweenplan to use and leave the factory	-0.03% per working time
Cumulative measurement uncertainty	U=2%(k=2)

Tab. III-1 device specification

Non-Clinical Test Conclusion 7.

Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

1EC 60601-1-1:1988+A1:1991+A2:1995, Medical Electrical Equipment- Part 1: General requirements for safety.

IEC 60601-2-22: 1995, Medical Electrical Equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment.

IEC 60825-1: 2007, Safety of laser products - Part 1: Equipment classification and requirements.

IEC 60601-1-2:2007, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance. Collateral standard: Electromagnetic compatibility - Requirements and tests.

ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity

ISO 10993-10:2002/Amd. 1: 2006, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity AMENDMENT 1

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ITEM	Proposed Device	Predicate DeviceK112031
Light type	Diode laser	Diode laser
Wavelength(nm)	808 nm	810 nm
Spot size	1.2 cm²	same
Diode ModuleMode	FHR Mode	Standard Mode	SHR Mode(Super Hair Removal )	HR Mode
Indications forUse	Intended for hairremoval, permanenthair reduction	Intended for hairremoval, permanenthair reduction	Intended for hairremoval, permanenthair reduction	Intended for hairremoval, permanent hairreduction
Fluency(energy density)	≤ 10 J/cm²	≤ 120 J/cm²	same	same
Repetition Rate	≤10 Hz	≤3 Hz	same	same
Pulse Duration	≤ 20 ms	5-200 ms	same	Same
Dimension	460 mmx365 mmx350mm (D x W x H)	20" x22.4"x47" (494mm x569mm x 120mm)
Weight	26 kg	110 lbs.(49 kg)

Technological Characteristics Comparison 8.

Tab. III-2 Technology Characteristics Comparison

9. Substantially Equivalent Conclusion

The wavelength of proposed device is similar as that of the slight difference of 2 nm will not raise new problems in safety and Effectiveness; The treatment modes and their corresponding IFU of the proposed device are covered by those of predicate device; this item is considered to be substantially equivalency; there is difference on the dimension and weight between proposed device and predicate device, the physical specification will not raise new problem in safety and effectiveness

The proposed device, Diode Laser, is determined to be Substantially Equivalent (SE) to the predicate device, Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for use with the Family of Soprano XL Multi-Application Platform (K112031) in respect of safety and effectiveness.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

DEPARTMENT OF HEALTH & HUMAN SERVICES

April 21, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Beijng Syntech Laser Co., Ltd. % Mid-Link Consulting Co., Ltd. Ms. Diana Hong, General Manager P.O. Box 237-023 Shanghai, 200237, China

Re: K123483

Trade/Device Name: Diode 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 Dated: February 21, 2013 Received: April 01, 2013

Dear Ms. Hong:

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

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Page 2 - Ms. Diana Hong, General Manager

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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 Small Manufacturers, International and Consumer Assistance 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 yours, FOR

Peter D. Ruimm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exhibit #5 Indications for Use

510(k) Number: Device Name:

Indications for Use:

The Diode Laser is intended for use in dermatologic and general surgical procedures.

The Standard Mode is intended for hair removal, permanent hair reduction.

The FHR Mode is intended for hair removal, permanent hair reduction.

The diode laser system is intended for use on all skin types I-VI), including tanned skin.

�PRESCRIPTION USE (Part 21 CFR 801 Subpart D) OOVER-THE-COUNTER USE (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R Ogden
2013.04.19 16:22:03 -04'00'

(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K123483

Page 1 of I

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.