The Dermatological Diode Laser Systems is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.

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 proposed device, Diode Laser Therapy System, is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);

There are 2 models included, T5 Pro and T8 Pro, the two models have same intended use, mechanism of action, principle and specification, only difference is the configuration.

The main components of proposed device shown as following: Handpiece, Touchscreen, Emergency Switch, Key Switch, Connector, Indicator Lamp, Foot Switch.

AI/ML Overview

This document describes a 510(k) submission for a Dermatological Diode Laser System, which is a medical device for hair removal and permanent hair reduction. The submission aims to demonstrate substantial equivalence to a predicate device.

Key Findings on Acceptance Criteria and Studies:

The submission explicitly states:

"No clinical study is included in this submission."

This immediately indicates that no study was conducted to prove the device meets specific performance acceptance criteria for hair removal or permanent hair reduction. The acceptance criteria and performance reported in the table below are based on the device's technical specifications and intended use, and the claim of substantial equivalence to a predicate device, rather than on clinical efficacy data.

1. Table of acceptance criteria and the reported device performance:

Since no clinical study was performed, there are no reported clinical performance metrics directly demonstrating hair removal or permanent hair reduction efficacy for this specific device. The acceptance is derived from the device's technical specifications being sufficiently similar to a legally marketed predicate device, and compliance with safety and electrical standards.

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance (as claimed for SE)
Intended Use	Hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as long-term, stable reduction in hair regrowth at 6, 9, and 12 months after treatment.	SAME as intended use
Laser Type	Diode Laser	Diode Laser
Laser Classification	Class IV	Class IV
Laser Wavelength	808 nm	808 nm
Spot Size	Not explicitly stated as a strict criterion, but noted predicate has 2.8 cm², proposed has 2.4 cm²	2.4 cm² (Different from predicate, but stated not to affect therapeutic effect)
Fluence	2-40 J/cm²	2-40 J/cm²
Frequency	1-10 Hz	1-10 Hz
Pulse Duration	Not explicitly stated as a strict criterion, but noted predicate has 3-400 ms, proposed has 10-400 ms	10-400 ms (Similar to predicate)
Electrical Safety	IEC 60601-1, IEC 60601-2-22	Complies with IEC 60601-1, IEC 60601-2-22
EMC	IEC 60601-1-2	Complies with IEC 60601-1-2
Laser Safety	IEC 60601-2-22, IEC 60825	Complies with IEC 60601-2-22, IEC 60825
Biocompatibility	ISO 10993-1 (for patient contact materials)	No cytotoxicity, no evidence of sensitization or irritation for patient-contacting materials (Quartz in handpiece and handpiece tip)
Software Validation	(Standard V&V procedures)	Performed

2. Sample size used for the test set and the data provenance:

No test set for clinical performance was used, as no clinical study was performed. Only non-clinical tests (electrical safety, EMC, laser safety, biocompatibility, software validation) were conducted on the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as no clinical test set requiring expert ground truth was used.

4. Adjudication method for the test set:

Not applicable, as no clinical test set requiring adjudication was used.

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:

Not applicable. This device is a laser system for physical hair removal, not an AI-assisted diagnostic or interpretation tool. No MRMC study was conducted.

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

Not applicable. This device is a physical laser system, not an algorithm or AI.

7. The type of ground truth used:

For non-clinical tests: Ground truth was defined by compliance with established international standards (e.g., IEC 60601-1, IEC 60601-2-22, IEC 60825-1, ISO 10993-5, ISO 10993-10) and the device's own design specifications.

8. The sample size for the training set:

Not applicable. This device is a hardware laser system, not an AI/machine learning model that requires a training set.

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

Not applicable. As above, no training set was used.

Summary

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April 23, 2021

Zhuolu Jontelaser Manufacturing Technology Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd Rm. 912, Building #15, XiYueHui, No.5, YiHue North Rd., FangShan District BeiJing, BeiJing 102401 China

Re: K202257

Trade/Device Name: Dermatological Diode Laser 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: March 23, 2021 Received: March 26, 2021

Dear Ray Wang:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202257

Device Name Dermatological Diode Laser Systems

Indications for Use (Describe)

The Dermatological Diode Laser Systems is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.

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.

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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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 Title 21, CFR Section 807.92.

1. Date of Preparation
  08/06/2020
1. Applicant Name and Address
  Zhuolu Jontelaser Manufacturing Technology Co., Ltd. No. 31, Sanguanmiao Alley, Zhuolu Town, Zhuolu County, Zhangjiakou City, Hebei, China, 072750
Contact Person Information 3. Karen Liu General Manager Tel: +86-13911459627 Fax: +86-10- 57212057 Email: 919309354@qq.com
1. Submission Correspondent

Mr. Ray Wang Beijing Believe Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing City, China, 102401 Tel: +86-18910677558 Fax: +86-10-56335780 Email: ray.wang(@believe-med.com

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Identification of Proposed Device 5.
Trade Name: Dermatological Diode Laser Systems Common Name: Powered Laser Surgical Instrument Model(s): T5 Pro/T8 Pro

Classification Name: Powered Laser Surgical Instrument Classification: II; Product Code: GEX; Regulation Number: 21 CFR 878.4810; Review Panel: General& Plastic Surgery;

Identification of Primary Predicate 6. 510(k) Number: K192569 Product Name: Diode Laser Therapy System Manufacturer: San He Lefis Electronics Co., Ltd.

Device Description 7.

The proposed device, Diode Laser Therapy System, is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);

There are 2 models included, T5 Pro and T8 Pro, the two models have same intended use, mechanism of action, principle and specification, only difference is the configuration. The detailed difference shown as following:

Model	T5 Pro	T8 Pro
Size	635246cm	4944139cm
Weight	48Kg	57Kg

Table 1 The Difference of Models

The main components of proposed device shown as following:

Components	Function Description	Applied Model(s)
Handpiece	Deliver the laser to area to be treated	T5 Pro/T8 Pro
Touchscreen	The user interface and for controlling of the system	T5 Pro/T8 Pro
Emergency Switch	Stop the system in case of emergency situation	T5 Pro/T8 Pro
Key Switch	Start the system	T5 Pro/T8 Pro
Connector	Connection of the device with the handpiece	T5 Pro/T8 Pro
Indicator Lamp	Indicate current working state of the appliance	T5 Pro/T8 Pro
Foot Switch	Activate the laser emission	T5 Pro/T8 Pro

Table 2 Main Components of Proposed Device

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Indication For Use 8.
The Dermatological Diode Laser Systems is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. 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.
1. Substantially Equivalent (SE) Comparison

ITEM	Proposed Device	Predicate Device	Remark
Product Code	GEX	GEX	SAME
Regulation No.	21 CFR 878.4810	21 CFR 878.4810	SAME
Class	2	2	SAME
Where used	Hospital	Hospital	SAME
Intended Use	The Dermatological Diode Laser Systems is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. 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.	The Diode Laser Therapy System is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. 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.	SAME
Configuration	Main UnitHandpieceFoot Control	Main UnitHandpieceFoot Control	SAME
Principle ofOperation	Diode Laser	Diode Laser	SAME

Table 3 General Comparison

ITEM	Proposed Device	Predicate Device	Remark
Laser Type	Diode Laser	Diode Laser	SAME
Laser Classification	Class IV	Class IV	SAME
Laser wavelength	808 nm	808 nm	SAME
Spot Size	2.4 cm2	2.8 cm2	Analysis 1
Fluence	2-40 J/cm2	2-40 J/cm2	SAME
Frequency	1-10 Hz	1-10 Hz	SAME
Pulse Duration	10-400 ms	3-400 ms	Similar
Power Supply	AC 100-240V/50Hz-60Hz	AC 110V/50Hz-60Hz	SAME

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Dimension	4944139cm	5160100cm	Analysis 2
	635246cm
Weight	57KG	45kg	Analysis 3
	48KG

Table 5 Safety Comparison

Item	Proposed Device	Predicate Device	Remark
EMC, Electrical and Laser Safety
Electrical Safety	Comply with IEC 60601-1, IEC60601-2-22	Comply with IEC 60601-1, IEC60601-2-22	SAME
EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2	SAME
Laser Safety	Comply with IEC 60601-2-22, IEC 60825	Comply with IEC 60601-2-22, IEC 60825	SAME
Patient Contact Materials and Biocompatibility
Patient ContactMaterials	Quartz in handpiece and handpiece tip(aluminum and SiO2)	Stainless steel and Sapphire in handpiece	Analysis 4
Cytotoxicity	No Cytotoxicity	Comply with ISO 10993-1	SAME
Sensitization	No evidence of sensitization
Irritation	No evidence of irritation

Analysis 1

The proposed device is different in Spot Size from the predicate, Spot size only affects the area of treatment, not affect the therapeutic effect. Therefore, this difference will not affect the substantially equivalency.

Analysis 2/3

The proposed device is different in dimension and weight from the proposed device is a trolley type, while the predicate device is a desktop type. By complying with IEC 60601-1, the mechanical performance of the proposed device is determined to be accepted, therefore, this difference will not affect the substantially equivalency.

Analysis 4

The proposed device is different in patient-contacting materials. But all patient-contacting materials used in proposed device has been evaluated as ISO 10993-1, as the results of evaluation, there is no biocompatibility concerns raised from the patient-contacting materials used in proposed device, so this different will not affect the substantially equivalency.

10. Non-Clinical Test Conclusion

Non clinical 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:

IEC 60601-1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance;
IEC 60601-2-22:2007, Medical Electrical Equipment - Part 2-22: Particular Requirements For

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Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment;

IEC 60825-1:2014, Safety of laser products - Part 1: Equipment classification and requirements.
IEC 60601-1-2:2014, 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 10993-10:2010, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity
Software Validation & Verification Test
1. Clinical Testing

No clinical study is included in this submission.

1. Conclusion
  Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) 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.