The Diode Laser Therapy Systems are intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Device Description

The Diode Laser Therapy Systems mainly consist of console, treatment hand piece and a foot switch. The diode laser emits wavelength of 808nm from the treatment hand piece, the wavelength effectively penetrates deep into and absorbed by the target chromophore. The adequate pulse duration, energy density and epidermal cooling ensure an adequate thermal damage to the target tissue without damaging the surrounding tissue to achieve effective hair removal.

AI/ML Overview

Based on the provided document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

Note: This document is a 510(k) summary for a medical device (Diode Laser Therapy Systems, Model SDL-B) and focuses on establishing substantial equivalence to a predicate device, not necessarily on demonstrating clinical efficacy through a traditional comparative effectiveness study with pre-defined acceptance criteria for performance metrics like sensitivity or specificity. The "acceptance criteria" here refer to meeting regulatory standards and demonstrating equivalence in function and safety.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Standard Met	Reported Device Performance
Intended Use Equivalence	To be substantially equivalent to the predicate device for hair removal and permanent hair reduction on all skin types (Fitzpatrick I-VI), with a definition of permanent hair reduction as long-term, stable reduction measured at 6, 9, and 12 months post-treatment.	The proposed device, Diode Laser Therapy Systems, has the same intended use as the predicate device (Emvera Diolux, K123257). Both are intended for hair removal and permanent hair reduction on all skin types (Fitzpatrick I-VI), with the same definition for permanent hair reduction.
Technological Equivalence	Demonstrate similar technological characteristics or that differences do not raise new questions of safety or effectiveness.	Wavelength: Same (808 nm) Fluence (Energy Density): Same (<120 J/cm²) Frequency: Same (1Hz-10Hz) Material: Same (Sapphire) Cooling: Same (Water cooling) Output Power: Proposed device (500W) is less than predicate (600W). Regarded as acceptable. Pulse Duration: Proposed device (5ms-400ms) has a smaller maximum pulse duration than predicate (5ms-625ms). Regarded as acceptable. Spot Size: Proposed device (12mm x 10mm) is smaller than predicate (12mm x 12mm). Regarded as acceptable. Anatomical Sites: Proposed device covers fewer anatomical sites (Axilla, Face, bikini, Upper limb and lower limb) than predicate (Axilla, Face, bikini, Upper limb and lower limb, brow, upper lip, neck, chest, back). Regarded as acceptable.
Biocompatibility	Compliance with ISO 10993-1.	Testing included Cytotoxicity, Sensitization, and Irritation for the laser output window. The evaluation was conducted in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1. Results are assumed to be compliant as the device was cleared.
Electrical Safety & EMC	Compliance with IEC 60601-1, IEC 60825-1, and IEC 60601-1-2.	The system complies with IEC 60601-1 (safety), IEC 60825-1 (laser safety), and IEC 60601-1-2 (EMC).
Software Verification & Validation	Compliance with FDA Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."	Software V&V testing was conducted, and documentation was provided. The software was deemed a "moderate" level of concern. Results are assumed to be compliant as the device was cleared.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not report any clinical test set or data provenance for human subjects. The performance data presented are primarily non-clinical: biocompatibility testing, electrical safety and EMC testing, and software verification and validation. The claim of substantial equivalence is largely based on the device's technical specifications being similar to or safer than the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as no clinical test set with human subject data requiring expert ground truth establishment is described in this 510(k) summary. The "ground truth" for this submission revolves around meeting engineering and biocompatibility standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as no clinical test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study was not done. This 510(k) is for a laser therapy system (hardware device), not an AI/software as a medical device (SaMD) that assists human readers.

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

A standalone performance study for an algorithm was not done. This device is a physical laser system for direct patient treatment, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context refers to established regulatory and engineering standards:

Biocompatibility: Adherence to ISO 10993-1 standards (e.g., negative results for cytotoxicity, sensitization, irritation).
Electrical Safety & EMC: Compliance with IEC 60601-1, IEC 60825-1, and IEC 60601-1-2 standards.
Software V&V: Adherence to FDA guidance for software in medical devices.
Substantial Equivalence: Comparison of technical specifications and intended use against a legally marketed predicate device.

8. The sample size for the training set

This information is not applicable as this submission does not describe an AI model with a training set. The "training" for this device would refer to its engineering design and validation against specified requirements.

9. How the ground truth for the training set was established

This information is not applicable as this submission does not describe an AI model with a training set. The "ground truth" for the device's development was established through engineering specifications, regulatory standards, and performance evaluation against those standards.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

February 9, 2016

Beijing Sincoheren Science And Tech. Development Co., Ltd % Mr. Mike Gu Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technology Service Co., Ltd 7th Floor, Jingui Business Building, No.982 Congyun Rd. Baiyun District Guangzhou, 510420 CN

Re: K152898

Trade/Device Name: Diode Laser Therapy Systems 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: September 20, 2015 Received: October 1, 2015

Dear Mr. Gu:

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

{1}------------------------------------------------

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 yours,

Jennifer R. Stevenson -S

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K152898

Device Name

Diode Laser Therapy Systems, Model SDL-B

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image is a close-up of a logo or symbol set against a green background. The logo features stylized white lines that form an abstract design. The lines appear to be interconnected, creating a sense of unity or network. The overall impression is modern and clean, with the white lines contrasting sharply against the solid green backdrop.

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

l. SUBMITTER

Beijing Sincoheren Science and Technology Development Co., Ltd. Room 305, No.43, Xizhimen North Street, Haidian District, Beijing, 100044, China Phone: +86-(0)10-57734966

Fax: +86-(0)10-82290038

Primary Contact Person:	Mike Gu
	Regulatory Affairs Manager
	OSMUNDA Medical Device Consulting Co., Ltd
	Tel: (+86) 20-6232 1333
	Fax: (+86) 20-8633 0253
Secondary Contact Person:	Xin Wang
	Quality Manager
	Beijing Sincoheren Science and Technology Development
	Co., Ltd.
	Tel: (+86) 10-82294249-8002
	Fax: (+86) 10-82294249-8007

II. DEVICE

Name of Device:	Diode Laser Therapy Systems, Model SDL-B
-----------------	------------------------------------------

Name of Device:	Diode Laser Therapy Systems, Model SDL-B
Common/Usual Name:	Diode Laser Therapy Systems
Classification Names:	Powered Laser Surgical Instrument (21 CFR 878.4810)
Regulation Class:	II
Product Code:	GEX

PREDICATE DEVICE lll.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image is a green square with a white design on it. The design appears to be abstract, possibly representing a stylized plant or organic form. The white color contrasts sharply with the green background, making the design stand out. The overall impression is simple and modern.

Emvera Diolux, K123257

This predicate has not been subject to a design-related recall. No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

V. INDICATION FOR USE

The Diode Laser Therapy Systems are intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI).

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Specification	Predicate device	Proposed device	Discussion ofDifferences
K number	K123257	--
Manufacturer	Emvera Technologies, LLC.	Beijing Sincoheren Science andTechnology Development Co., Ltd.
Device name	Emvera Diolux	Diode Laser Therapy Systems
Intended Use	The Emvera Diolux is intended forhair removal, permanent hairreduction on all skintypes (Fitzpatrick skin type I-VI).Permanent hair reduction isdefined as the long-term, stablereduction in the number of hairsregrowing when measured at 6, 9and 12 months after thecompletion of a treatmentregime.	The Diode Laser Therapy Systemsare intended for hair removal,permanent hair reduction on all skintypes (Fitzpatrick skin type I-VI).Permanent hair reduction is definedas the long-term, stable reduction inthe number of hairs regrowing whenmeasured at 6, 9 and 12 monthsafter the completion of a treatmentregime.	same

VI. SUBSTANTIAL EQUIVELENCE

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows a green square with a white design on it. The design appears to be a stylized representation of a plant or a symbol. The white design is abstract and fills most of the square, with some parts extending to the edges.

Specification	Predicate device	Proposed device	Discussion of Differences
Wavelength(nm)	808	808	Same
Output power(W)	600	500	Less than theoutput ofpredicatedevice.
Fluence (EnergyDensity)	<120 J/cm²	<120 J/cm²	Same
Pulse Duration	5ms-625ms	5ms-400ms	Themaximumpulseduration issmaller thanthe predicatedevice.
Frequency	1Hz-10Hz	1Hz-10Hz	Same
Spot Size	12mm × 12mm	12mm × 10mm	Smaller thanthe predicatedevice.
Material	Sapphire	Sapphire	Same
Cooling	Water cooling	Water cooling	Same
Anatomical Sites	Axilla, Face, bikini, Upper limband lower limb, brow, upper lip,neck, chest, back	Axilla, Face, bikini, Upper limb andlower limb	Less than thepredicatedevice.

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

The biocompatibility evaluation for the device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The laser output window of testing included the following tests:

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image is a close-up of a logo or symbol set against a green background. The logo appears to be white and stylized, possibly representing a letter or a combination of abstract shapes. The white design contrasts sharply with the green, making it stand out. The image is cropped, focusing on the central part of the logo.

Cytotoxicity
Sensitization
Irritation

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the device. The system complies with the IEC 60601-1 and IEC 60825-1 standards for safety and the IEC 60601-1-2 standard for EMC.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure of latent design flaw could directly result in minor injury to the patient or operator.

VIII. CONCLUSION

The Diode Laser Therapy Systems and its application comply with standards as detailed in section 9, 11 and 17 of this premarket notification. Non-clinical tests determined that the Diode Laser Therapy Systems to be as safe, as effective and performance is substantially equivalent to the predicate device.

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.