Diode Laser Machine, Model Number: BM-100

• K Number: K211335
• Device Name: Diode Laser Machine, Model Number: BM-100
• Manufacturer: Zhengzhou Bestview St Co., Ltd.
• Date Cleared: 2021-07-28 ( 86 days)
• Product Code: GEX
• Regulation Number: 878.4810

Intended Use

The Diode Laser Machine (Model: BM-100) 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 incorporates a diode laser that emits invisible infrared laser radiation centered on a wavelength of 808 nm. Main components of the device include the laser console, liquid crystal display (LCD) touchscreen control panel, and laser handpiece. The device emits pulses of the 808 nm infrared laser emissions at pulse widths, repetition frequency, and energy levels, conductive to hair removal. The device incorporates water cooling, air cooling fan, and switches/buttons to control the laser output. The device is powered via an alternating current power source.

Predicate Devices

K162659

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard diode laser system for hair removal with no mention of AI or ML components in the device description, intended use, or performance studies.

Therapeutic

No.
The device is intended for hair removal and permanent hair reduction, which are considered cosmetic procedures rather than therapeutic treatments for a disease, injury, or other medical condition.

Diagnostic

No.
The device's intended use is hair removal and permanent hair reduction, which are therapeutic procedures, not diagnostic ones.

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components such as a laser console, handpiece, cooling systems, and power source, indicating it is a physical device with integrated software, not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is clearly stated as "hair removal, permanent hair reduction". This is a therapeutic/cosmetic procedure performed directly on the patient's body.
• Device Description: The device is a laser machine designed to emit light energy for hair removal. It does not involve the examination of specimens (like blood, urine, or tissue) outside of the body, which is the defining characteristic of an IVD.
• Lack of IVD-related information: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.

In summary, this device is a therapeutic medical device used for a physical treatment, not a diagnostic device used to analyze samples outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Diode Laser Machine (Model: BM-100) 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.

Product codes (comma separated list FDA assigned to the subject device)

GEX

Device Description

The proposed device incorporates a diode laser that emits invisible infrared laser radiation centered on a wavelength of 808 nm. Main components of the device include the laser console, liquid crystal display (LCD) touchscreen control panel, and laser handpiece. The device emits pulses of the 808 nm infrared laser emissions at pulse widths, repetition frequency, and energy levels, conductive to hair removal. The device incorporates water cooling, air cooling fan, and switches/buttons to control the laser output. The device is powered via an alternating current power source.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Hospital

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 conform to 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 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 A delay-type hypersensitivity
• Software Validation & Verification Test

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K162659

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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Image /page/0/Picture/0 description: The image contains 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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 28, 2021

Zhengzhou Bestview St Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, BeiJing 102401 China

Re: K211335

Trade/Device Name: Diode Laser Machine, Model: BM-100 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: April 28, 2021 Received: May 3, 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 ([e-mail]) or phone [phone] 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K211355

Device Name Diode Laser Machine Model: BM-100

Indications for Use (Describe)

The Diode Laser Machine (Model: BM-100) 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)

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 [e-mail]

"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."

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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.

• Date of Preparation 1.
  07/27/2021

• 2. Applicant Name and Address

Zhengzhou Bestview St Co., Ltd.

Room 2004, 20F, Lande Center, Huayuan Road, Jinshui District, 450000 Zhengzhou, Henan Province, China

• 3. Contact Person Information YangChun Jia General Manager Tel: [phone] Email: [e-mail]
• 4. Submission Correspondent

Mr. Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing City, China, 102401 Tel: [phone] Fax: [phone] Email: [e-mail]

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• 5. Identification of Proposed Device Trade Name: Diode Laser Machine Common Name: Powered Laser Surgical Instrument Model(s): BM-100 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: K162659 Product Name: Diode Laser Hair Removal System Manufacturer: Shandong Huamei Technology Co., Ltd.
• 7. Device Description

The proposed device incorporates a diode laser that emits invisible infrared laser radiation centered on a wavelength of 808 nm. Main components of the device include the laser console, liquid crystal display (LCD) touchscreen control panel, and laser handpiece. The device emits pulses of the 808 nm infrared laser emissions at pulse widths, repetition frequency, and energy levels, conductive to hair removal. The device incorporates water cooling, air cooling fan, and switches/buttons to control the laser output. The device is powered via an alternating current power source. Specification for the device are provided below.

• 8. Indication For Use
     The Diode Laser Machine (Model: BM-100) 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.

• Substantially Equivalent (SE) Comparison 9.

Table 3 General Comparison

ITEM	Proposed Device	Predicate Device (K162659)	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 Diode Laser Machine (Model:	The Diode Laser Hair Removal System is	SAME

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510(k) Summary

	BM-100) 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.	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.
Configuration	Main Unit	Main Unit	SAME
	Handpiece	Handpiece	SAME
Principle of Operation	Diode Laser	Diode Laser	SAME

Table 4 Performance Comparison

ITEM	Proposed Device	Predicate Device (K162659)	Remark
Laser Type	Diode Laser	Diode Laser	SAME
Laser Classification	Class IV	Class IV	SAME
Laser wavelength	808 nm	808 nm	SAME
Spot Size	2.25 cm2 (15mm x 15mm)	1.44 cm2
Fluence	0-120 J/cm2	1-120J/cm2	Similar
Frequency	1-10 Hz	05-15Hz	Similar
Pulse Duration	10-400 ms	5-400 ms	Similar
Power Supply	220/110 VAC/50Hz-60Hz	AC 110V/60Hz	SAME
Dimension	112 cm x 42 cm x 60cm	450mm x 550mm x 350mm
Weight	63 kg	52kg

Table 5 Safety Comparison

Item	Proposed Device	Predicate Device (K162659)	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	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 Contact
Materials	handpiece	handpiece	SAME
Cytotoxicity	No Cytotoxicity	Comply with ISO 10993-1	SAME
Sensitization	No evidence of sensitization
Irritation	No evidence of irritation

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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 conform to 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 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 A delay-type hypersensitivity

• Software Validation & Verification Test

• 11. Clinical Testing

No clinical study is included in this submission.

• 12. Conclusion
      The proposed device utilizes technological characteristics that are the same or are similar to the predicate device. The proposed device's technological characteristics do not raise new types of questions regarding safety and effectiveness, and performance testing conducted supports that the device can be used safety and effectively for the proposed indication for use above. Based on the comparison and analysis above, the proposed device is considered to be Substantially Equivalent (SE) to the predicate device.