Diode Laser Hair Removal System (MBT-Diode Laser)

• K Number: K241642
• Device Name: Diode Laser Hair Removal System (MBT-Diode Laser)
• Manufacturer: Beijing Mega Beauty Technology Co.,Ltd.
• Date Cleared: 2024-08-02 ( 56 days)
• Product Code: GEX
• Regulation Number: 878.4810

Intended Use

The Diode Laser Hair Removal System (Model: MBT-Diode Laser) 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

Diode Laser Hair Removal System (Model: MBT-Diode Laser) is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). 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 laser handle. The emission laser is activated by footswitch or handle button. The Diode Laser Hair Removal System consists of the following major components - The main console unit that incorporates the main CPU board, power supply modules, laser power supply, laser device, cooling system and switching module - Handpiece - Footswitch

Predicate Devices

K211335

Reference Devices

K200525

AI/ML (Artificial Intelligence / Machine Learning)

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

Therapeutic

Yes
The device is intended for hair removal and permanent hair reduction, which are considered therapeutic indications as they involve a physical intervention to alter or treat a condition (unwanted hair growth). Additionally, the device performance standards mention "surgical, cosmetic, therapeutic and diagnostic laser equipment."

Diagnostic

No
The device is described as a "Diode Laser Hair Removal System" intended for hair removal and permanent hair reduction. Its function is to perform a therapeutic or cosmetic procedure, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components such as a main console unit, handpiece, and footswitch, and describes the physical mechanism of laser emission for hair removal.

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 on all skin types". This is a therapeutic/cosmetic application, not a diagnostic one.
• Device Description: The description details a laser system that emits infrared radiation to target melanin in hair follicles. This is a physical interaction with the body, not an in vitro test of a biological sample.
• Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
  • Analyzing biological samples (blood, urine, tissue, etc.)
  • Detecting or measuring substances in biological samples
  • Providing information for diagnosis, monitoring, or screening of diseases or conditions.

The device is a surgical/therapeutic laser system used for a cosmetic procedure.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Diode Laser Hair Removal System (Model: MBT-Diode Laser) 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

GEX

Device Description

Diode Laser Hair Removal System (Model: MBT-Diode Laser) is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). 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 laser handle. The emission laser is activated by footswitch or handle button.

The Diode Laser Hair Removal System consists of the following major components

• The main console unit that incorporates the main CPU board, power supply modules, laser a. power supply, laser device, cooling system and switching module
• Handpiece b.
• Footswitch C.

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

Not Found

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 complies with the following standards:

• A IEC 60601-1 Edition 3.2 2020-08, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• A IEC 60601-1-2 Edition 4.1 2020-09, Medical Electrical Equipment-Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility-Requirements And Tests
• A IEC 60825-1:2014, Safety of laser products - Part 1: Equipment classification, and requirements

• IEC 60601-2-22: 2012 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

• ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity

• ISO 10993-10 Fourth edition 2021, Biological evaluation of medical devices - Part 10: Tests for skin A sensitization

• ISO 10993-23 First edition 2021-01, Biological evaluation of medical devices - Part 23: Tests for irritation

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

Not Found

Predicate Device(s)

K211335

Reference Device(s)

K200525

Predetermined Change Control Plan (PCCP) - All Relevant Information

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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August 2, 2024

Beijing Mega Beautv Technology 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, 102401 China

Re: K241642

Trade/Device Name: Diode Laser Hair Removal System (MBT-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: June 6, 2024 Received: June 7, 2024

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 (the 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 available 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.

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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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product: and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).

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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-devices/deviceadvice-comprehensive-regulatory-assistance/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.

TANISHA TANISHA L. HITHE -S L. HITHE -S Date: 2024.08.0

Tanisha Hithe 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

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K241642

Device Name

Diode Laser Hair Removal System (MBT-Diode Laser)

Indications for Use (Describe)

The Diode Laser Hair Removal System (Model: MBT-Diode Laser) 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.

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

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K241642 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: __________________________________________________________________________________________________________________________________________________

• Date of Preparation:2024/06/06 1.
• 2. Sponsor Identification

Beijing Mega Beauty Technology Co.,Ltd.

Room 1-524, Building No.4, Xinyuan Road No.27, Daxing District, Beijing, 102629 China.

Contact Person: Alex Yu Position: General Manager Tel: [phone] Fax: [phone] Email: [e-mail]

• 3. Designated 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, 102401, China

Tel: [phone] Fax: [phone] Email: [e-mail]

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• 4. Identification of Proposed Device
     Trade Name: Diode Laser Hair Removal System Common Name: Powered Laser Surgical Instrument Model(s): MBT-Diode Laser

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

• ર. Identification of Predicate Device(s) Predicate Device 510(k) Number: K211335 Product Name: Diode Laser Machine Manufacturer: Zhengzhou Bestview St Co., Ltd.
  Reference Device 510(k) Number: K200525 Product Name: Medical Diode Laser Hair Removal System Manufacturer:Weifang Mingliang Electronics CO., LTD.

• Device Description: 6.
  Diode Laser Hair Removal System (Model: MBT-Diode Laser) is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). 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 laser handle. The emission laser is activated by footswitch or handle button.

The Diode Laser Hair Removal System consists of the following major components

• The main console unit that incorporates the main CPU board, power supply modules, laser a. power supply, laser device, cooling system and switching module
• Handpiece b.
• Footswitch C.
• Indication For Use Statement: 7.

The Diode Laser Hair Removal System (Model: MBT-Diode Laser) 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.

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8. Substantially Equivalent (SE) Comparison

Table 7-1 General Comparison
Item	Proposed Device	Predicate Device
K211335	Reference Device
K200525	Remark
Device Name	Diode Laser Hair
Removal System	Diode Laser
Machine	Diode Laser
Machine	/
Classification
Regulation	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	SAME
Classification
Panel	General & Plastic
Surgery	General & Plastic
Surgery	General & Plastic
Surgery	SAME
Class	II	II	II	SAME
Product Code	GEX	GEX	GEX	SAME
Indication for use	The Diode Laser Hair
Removal 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.	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.	The Medical Diode
Laser Hair
Removal System is
used for
permanent reduction
in hair
regrowth defined as a
long term,
stable reduction in the
number of
hairs re-growing
when measured at
6, 9 and 12 months
after the
completion of a
treatment regimen.
Use on all skin types
( Fitzpatrick
I-VI), including
tanned skin.	SAME

Table 7-1 General Comparison

Table 7-2 Performance Comparison

| ITEM | Proposed Device | Predicate Device
K211335 | Reference Device
K200525 | Remark |
|-------------------------|-----------------|-----------------------------|-----------------------------|--------|
| Laser Type | Diode Laser | Diode Laser | Diode Laser | SAME |
| Laser
Classification | Class IV | Class IV | Class IV | SAME |
| Laser | 808nm | 808nm | 808nm | SAME |

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Wavelength
Spot Size	15mm×15mm	2.25cm²
(15mm×15mm)	1.44cm2
(1.2 x 1.2 cm)	SIMILAR
Fluence	1-55.96J/cm²	0-120J/cm²	48 J/cm²	Different
Frequency	1-10Hz	1-10Hz	1-10Hz	SAME
Pulse Duration	2-240ms	10-400ms	1-300ms	Different
Power Supply	110 VAC/50Hz-60Hz	220/110
VAC/50Hz-60Hz	220/110
VAC/50Hz-60Hz	Different
Dimension	650mm×580mm×
1210mm	112 cm × 42 cm ×
60cm	/	Different
Weight	68Kg	63Kg	/	Different

Analysis :

Different - Fluence

The proposed device has different Fluence from the predicate device.

For the difference on fluence between the predicate and proposed device(s), The Fluence of Predicte Device K211335 is 0-120./cm², while the propose device is 55.96 J/cm². It is lower than 120 J/cm², the safety of the product is no problem. However, the effectiveness cannot be determined, so we selected Reference Device K200525 with the same intended use for Fluence comparison,The Fluence of the Reference Device is 48J/cm², which is similar to the Fluence of the proposed device, so the effectiveness of the product is not affected.And the proposed device has passed the IEC60601-1 test, IEC60601-1-2 test, IEC60601-2-22 test. IEC60825-1 test and performance test, the safety and performance of the product can be ensured.

Different - Pulse Duration

The proposed device has different pulse duration from the predicate device.

For the difference on pulse duration between the predicate and proposed device(s), we can see that the pulse duration range of proposed device is within the range of the predicate device. The pulse duration between the proposed device and the predicate device only with minor difference. And we think this minor difference will not affect the effectiveness and safety. And the proposed device has passed the IEC60601-1 test, IEC60601-1-2 test, IEC60601-2-22 test, IEC60825-1 test and performance test, the safety and performance of the product can be ensured.

Different - Power Supply

The power supply for the proposed device is different from the predicate device. However, electrical safety and EMC test has been conducted on the proposed device and the test result show that the device can work normally under this power supply. Therefore, this difference will not affect safety and effectiveness of the proposed device.

Different - Dimension, Weight

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,

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this difference of dimension and weight have no effect the effectiveness and safety.

| Item | Proposed Device | Predicate Device
K211335 | 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 | | | |
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | SAME |
| Sensitization | No evidence of sensitization | No evidence of sensitization | SAME |
| Irritation | No evidence of irritation | No evidence of irritation | SAME |

Table 7-3 Safety Comparison

Non-Clinical Test Conclusion 9.

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:

• A IEC 60601-1 Edition 3.2 2020-08, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• A IEC 60601-1-2 Edition 4.1 2020-09, Medical Electrical Equipment-Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility-Requirements And Tests
• A IEC 60825-1:2014, Safety of laser products - Part 1: Equipment classification, and requirements

• IEC 60601-2-22: 2012 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

• ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity

ISO 10993-10 Fourth edition 2021, Biological evaluation of medical devices - Part 10: Tests for skin A sensitization

ISO 10993-23 First edition 2021-01, Biological evaluation of medical devices - Part 23: Tests for irritation

• 10. Clinical Test Conclusion
      No clinical study is included in this submission.

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• 11. Substantially Equivalent (SE) Conclusion
      Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device, Diode Laser Machine Model:BM-100 cleared under K211335.