The Dermatological Diode Laser Systems(Model: CM01D/CM02D) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-V), including tanned 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 Dermatological Diode Laser Systems utilize a semiconductor diode with invisible infrared radiation as a laser source to emit 808nm wavelength laser which is absorbed by melanin. The laser power is delivered to the treatment area via s laser handpiece. The emission laser is activated by a foot-switch. There are 2 models included,CM01D,CM02D, the two models have same mechanism of action, principle and specification, only difference is the configuration.

AI/ML Overview

The provided text is a 510(k) summary for a Dermatological Diode Laser System for hair removal and permanent hair reduction. This type of device falls under the "Laser surgical instrument for use in general and plastic surgery and in dermatology" regulation.

Critically, this document describes a traditional 510(k) submission, not a study performing a clinical evaluation of an AI/ML powered device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the demonstration of substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of specifications.

Therefore, many of the requested items related to "AI/ML device performance" (e.g., sample sizes for test/training sets, ground truth establishment for AI, MRMC studies, standalone algorithm performance) are not applicable to this document as it does not describe an AI/ML powered medical device.

Here's a breakdown of the requested information based on the provided document, highlighting what is and isn't applicable:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria for this 510(k) submission are primarily based on demonstrating substantial equivalence to the predicate device (K180353) and reference device (K142845), and compliance with various international standards. The "reported device performance" in this context refers to the device's technical specifications and the successful completion of non-clinical tests proving compliance with safety and performance standards.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Acceptance Criteria Category	Specific Criteria (Inferred from document)	Reported Device Performance / Evaluation
Primary Indication for Use	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.	Met by Substantial Equivalence: The Indications for Use statement is "Same" as the predicate and reference devices, indicating that the device serves the same purpose. The efficacy for "permanent hair reduction" is not demonstrated via a new clinical study in this submission, but rather through equivalence to legally marketed devices cleared for this indication.
Technical Specifications (for Substantial Equivalence)	Laser Type: Diode LaserLaser Classification: Class IVLaser Wavelength: Approx. 808 nmSpot Size: Comparable to predicate/reference, with acceptable differencesFluence: Within range of predicate/reference, with acceptable differencesFrequency: Within range of predicate, with acceptable differencesPulse Duration: Comparable to predicate, with acceptable differencesPower Supply: Consistent with predicate/referenceDimension/Weight: Acceptable differences that do not impact safety/effectiveness	Met:- Laser Type: Diode Laser (Same)- Laser Classification: Class IV (Same)- Laser Wavelength: 808 nm (Same as predicate, similar to reference 810 nm)- Spot Size: CM01D: 10x30 mm; CM02D: 9x12 mm. Noted as "Analysis" – accepted because it only affects area of treatment, not therapeutic effect.- Fluence: CM01D: 5-100 J/cm2; CM02D: 3-30 J/cm2. Noted as "Analysis 2" – accepted as "very slight" difference and within range of predicate/reference, and safety confirmed by standard compliance.- Frequency: CM01D: 1-10 Hz; CM02D: 1-3 Hz. Noted as "Analysis 5" – accepted as within predicate range and safety confirmed by standard compliance.- Pulse Duration: CM01D: 15-400 ms; CM02D: 35-400 ms. Noted as "Similar" to predicate's 10-400 ms.- Power Supply: AC 110V/60Hz (Same as predicate, similar to reference).- Dimension/Weight: Noted as "Analysis 3/4" – accepted as mechanical performance is covered by IEC 60601-1 compliance.
Safety Standards Compliance	Electrical Safety, EMC, Laser Safety, Biocompatibility (Cytotoxicity, Sensitization, Irritation)	Met via Non-Clinical Testing:- Electrical Safety: Complies with ES60601-1:2005+A1:2012, IEC 60601-2-22:2007 + A1:2012.- EMC: Complies with IEC 60601-1-2:2014.- Laser Safety: Complies with IEC 60825-1:2014, IEC 60601-2-22.- Biocompatibility: Complies with ISO 10993-5:2009 (Cytotoxicity - "No Cytotoxicity"), ISO 10993-10:2002/Amd. 1: 2006 (Irritation - "No evidence of irritation"; Sensitization - "No evidence of sensitization"). Patient contact materials (Tip of Handle, Device Housing) verified by testing per ISO 10993-1.
Software Validation	Software verification and validation activities were carried out. The product software is safe and effective.	Met: "Verification and validation activities include the verification and validation of product function, product performance and product interface. All verification and validation activities can meet the specified requirements, and the product software is safe and effective." (According to "guidance for the content of premarket submissions for software contained in medical devices").

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

Not Applicable. This submission relies on substantial equivalence through non-clinical testing (safety standards, performance specifications) and does not include a clinical study with a "test set" of patient data for evaluating device performance in the way an AI/ML device would.
The document explicitly states: "No clinical study is included in this submission."

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)

Not Applicable. As there is no clinical "test set" and no AI/ML component, there's no need for experts to establish ground truth in this context. The "ground truth" for this submission are the established safety and performance standards and the specifications of the predicate device.

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

Not Applicable. See point 3.

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 is not an AI/ML device, and no MRMC study was performed.

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

Not Applicable. This is not an AI/ML device.

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

The "ground truth" for demonstrating the safety and effectiveness of this device in the context of a 510(k) submission are:
- Established regulatory standards and consensus standards (e.g., IEC 60601 series, ISO 10993 series) for electrical safety, electromagnetic compatibility, laser safety, and biocompatibility.
- The performance and safety profile of the legally marketed predicate device (K180353) and reference device (K142845), against which the new device demonstrated substantial equivalence in its indications for use and technical specifications.

8. The sample size for the training set

Not Applicable. There is no AI/ML component requiring a training set of data.

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

Not Applicable. See point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 26, 2021

Beijing HuaCheng Taike Technology Co., Ltd. % Hui Liu Official Correspondent Beijing Believe Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, Beijing 102401 China

Re: K210663

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: February 27, 2021 Received: March 5, 2021

Dear Hui Liu:

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 and Part 809); 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 mediation-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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210663

Device Name

Dermatological Diode Laser Systems

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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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.

The assigned 510(k) Number: K210663

1. Date of Preparation
  04/15/2021
1. Sponsor

Beijing HuaCheng Taike Technology Co., Ltd.

5102P,Floor1,Building5,No.17Yunshannanlu Road, Tongzhou Industrial Development Zone,Tongzhou district, 101113 Beijing, P.R. China Contact Person: Li Yi Position: General Manager Tel: +86 15810861388 Fax: +8610 61592593 Email: alex@cosmedplus.com

Submission Correspondent 3.
Contact Person:

Mr. Ray Wang(Primary)

Tel: +86-18910677558

Fax: +86-10-52214696

Email: ray.wang@believe-med.com

Ms. Hui Liu (Secondary) Tel: +86-15922145259 Fax: +86-10-52214696 Email: hui.liu@believe-med.com

Beijing Believe Technology Service Co., Ltd.

Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, China,102401

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1. Identification of Proposed Device
  Trade Name: Dermatological Diode Laser Systems Common Name: Powered Laser Surgical Instrument Model(s): CM01D/CM02D

Regulatory Information: Classification Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Classification: II; Product Code: GEX; Regulation Number: 21 CFR 878.4810;

Indication For Use:

The Dermatological Diode Laser Systems(Model:CM01D/CM02D) 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 న్.

There are 2 models included,CM01D,CM02D, the two models have same mechanism of action, principle and specification, only difference is the configuration. The detailed difference shown as following:

	CM01D	CM02D
Display	15.6" color touch LCD screen	4.3" color touch LCD screen
Treatment laser spot	10×30 mm	9× 12 mm
Pulse width	15-400 ms (continuously adjustable )	35-400 ms ( continuously adjustable )
Energy density	05-100J/ cm2 (continuously adjustable	03-30J/ cm2 ( continuously adjustable )
Pulse frequency	1-10Hz	1-3Hz
Size	635246cm	4944139cm
Weight	75Kg	3Kg

Table 1 The Difference of Models

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1. Identification of Predicate Device
  Predicate Device 510(k) Number: K180353 Product Name: Diode Laser Hair Removal Device Manufacturer: Zhengzhou PZ Laser Slim Technology Co., Ltd

Reference Device 510(k) Number: K142845 Product Name: SILKPRO Laser Hair Removal System Manufacturer: Wuhan Lotuxs Technology Company, Ltd.

1. Non-Clinical Test Conclusion
  Non clinical tests were conducted to verify that the proposed device met all design specifications as was to be as safe, as effective, and perform as well as the legally marketed predicate devices.. The test results demonstrated that the proposed device complies with the following standards:
ES60601-1:2005+A1:2012 Medical Electrical Equipment - Part 1: General AAMI Requirements for Safety And Essential Performance
IEC 60601-2-22:2007 + A1:2012, Medical Electrical Equipment - Part 2: Particular requirements for 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 - Electromagnetic Compatibility
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
Software Validation & Verification Test

According to "guidance for the content of premarket submissions for software contained in medical devices" issued by FDA, software verification and validation activities were carried out. Verification and validation activities include the verification and validation of product function, product performance and product interface. All verification and validation activities can meet the specified requirements, and the product software is safe and effective.

Clinical Test Conclusion 8.
No clinical study is included in this submission.
Comparison with Predicate and Reference Devices 9.

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Table 2 General Comparison

ITEM	Proposed Device	Predicate Device (K180353)	Reference Device (K142845)	Remark
Product Code	GEX	GEX	OHT	Same
Regulation No.	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	Same
Class	2	2	2	Same
Indication For Use	The Dermatological Diode Laser Systems(Model:CM01D/CM02D) 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 hair removal device 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.	SILKPRO is an over-thecounter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. SILKPRO is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime.	Same
Configuration	Main Unit	Main Unit	/	Same
	Handpiece	Handpiece	/	Same
	Foot Control	Foot Control	/	Same
Principle ofOperation	Diode Laser	Diode Laser	Diode Laser	Same

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ITEM	Proposed Device	Predicate Device (K180353)	Reference Device (K142845)	Remark
Laser Type	Diode Laser	Diode Laser	Diode Laser	Same
LaserClassification	Class IV	Class IV	Class IV	Same
Laserwavelength	808 nm	808 nm	810 nm	Same
Spot Size	CM01D:10 × 30 mmCM02D:9× 12 mm	$1.44 cm^2$	9mm×9mm (0.81cm²)	Analysis
Fluence	CM01D:5-100J/ cm2CM02D:03-30J/ cm2	1-100J/ cm2	5-25J/cm2	Analysis 2
Frequency	CM01D: 1 - 10 Hz;CM02D: 1 - 3 Hz	1-20Hz	/	Analysis5
Pulse Duration	CM01D:15-400 msCM02D:35-400 ms	10-400ms	/	Similar
Power Supply	AC 110V/60Hz	AC 110V/60Hz	AC100~240V, 50/60Hz	Same
Dimension	CM01D:65cmX65cmX123cmCM02D:253mm210mm193mm	560mm x 380mm x1 180mm	/	Analysis
Weight	CM01D:75KGCM02D:3kg	60kg		Analysis

Table 3 Performance Comparison

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 safety and effectiveness.

Analysis 2

The proposed device is different in fluence from the predicate device, the difference is very slight. Fluence of the proposed device is within the range of the predicate and reference devices.And the proposed device has passed the IEC60601-1 test, IEC60601-1-2 test, IEC60601-2-22 test ,IEC60825-1 test, the safety and performance of the product can be ensured. So the proposed device is determined to be as safe, as effective, and performs as well as the legally marketed predicate devices.

Analysis 3/ 4

The proposed device is different in dimension and weight from the predicate device. 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 safety and effectiveness.

Analysis 5

The proposed device is different in Frequency from the predicate device, the frequency is the number of times light is emitted in a second. The Frequency of the proposed device is within the range of the

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predicate device.And the proposed device has passed the IEC60601-1 test, IEC60601-1-2 test, IEC60601-2-22 test ,IEC60825-1 test, the safety and performance of the product can be ensured. therefore, this difference will not affect the safety and effectiveness.

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Item	Proposed Device	Predicate Device (K180353)	Reference Device (K142845)	Remark
EMC, Electrical and Laser Safety
Electrical Safety	Comply with IEC 60601-1, IEC 60601-2-22	Comply with IEC 60601-1, IEC 60601-2-22	Comply with IEC 60601-1, IEC 60601-2-22	Same
EMC	Comply with IEC 60601-1-2	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	Comply with IEC 60601-2-22, IEC 60825	Same
Patient Direct/Indirect Contact Materials and Biocompatibility
PatientDirect/IndirectContact Materials	Tip of Handle (6061 Aluminium &Quartz )Device Housing (Acrylonitrile ButadieneStyrene)	Sapphire in handpiece	Stainless steel and Sapphire inhandpiece	Analysis6
Cytotoxicity	No Cytotoxicity	No Cytotoxicity	Comply with ISO 10993-1	Same
Sensitization	No evidence of sensitization	No evidence of sensitization
Irritation	No evidence of irritation	No evidence of irritation

Table 4 Safety Comparison

Analysis 6:

The proposed device is different in Patient Indirect Contact Materials from the predicate device, to confirm that the components and materials contained in the finished device as identified above are not adverse to human tissue, the biocompatibility testing was performed in accordance with ISO 10993-1: 2009 and guidance document entitled Blue Book Memo, G95-1, Use of International Standard ISO-10993, and Biological Evaluation of Medical Devices: Part 1: Evaluation and Testing.The results for the biocompatibility testing showed that there are no negative impacts from the materials that are used in the proposed device, therefore, this difference will not affect the safety and effectiveness.

10. Conclusion

Based on the comparison and analysis above, the proposed device is determined to be as safe, as effective, and performs as well as the legally marketed 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.