(56 days)
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.
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
The provided text is a 510(k) Summary for a Diode Laser Hair Removal System (MBT-Diode Laser). It describes the device, its intended use, and a comparison to a predicate device to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not outline specific, quantified acceptance criteria for the new device as would be seen in a clinical study. Instead, it demonstrates substantial equivalence to a predicate device by comparing technical specifications and adherence to recognized standards.
The table below summarizes the technical comparison provided, where "acceptance criteria" can be interpreted as demonstrating equivalence or justification for differences compared to the predicate/reference devices:
| Feature | Acceptance Criteria (Comparison to Predicate/Reference) | Reported Device Performance (Proposed Device) |
|---|---|---|
| General | ||
| Device Name | NA (for comparison) | Diode Laser Hair Removal System |
| Classification Regulation | SAME as predicate (21 CFR 878.4810) | 21 CFR 878.4810 |
| Classification Panel | SAME as predicate (General & Plastic Surgery) | General & Plastic Surgery |
| Class | SAME as predicate (II) | II |
| Product Code | SAME as predicate (GEX) | GEX |
| Indications for Use | SAME as predicate: Hair removal, permanent hair reduction on all skin types (Fitzpatrick I-VI), including tanned skin. Permanent hair reduction defined as long-term, stable reduction measured at 6, 9, and 12 months post-treatment. | Same as criterion |
| Performance (Technical) | ||
| Laser Type | SAME as predicate (Diode Laser) | Diode Laser |
| Laser Classification | SAME as predicate (Class IV) | Class IV |
| Laser Wavelength | SAME as predicate (808nm) | 808nm |
| Spot Size | SIMILAR to predicate (15mm x 15mm vs. 2.25cm², 1.44cm²) | 15mm x 15mm |
| Fluence | Different from predicate (0-120 J/cm²), but justified as lower (55.96 J/cm²) and similar to reference device (48 J/cm²) for effectiveness. Safety ensured by compliance with standards. | 1-55.96 J/cm² |
| Frequency | SAME as predicate (1-10Hz) | 1-10Hz |
| Pulse Duration | Different from predicate (10-400ms), but within predicate range (2-240ms) and considered a minor difference not affecting effectiveness/safety. Safety ensured by compliance with standards. | 2-240ms |
| Power Supply | Different from predicate (220/110 VAC/50Hz-60Hz), but electrical safety and EMC tests conducted ensure normal operation. | 110 VAC/50Hz-60Hz |
| Dimension | Different from predicate (112 cm x 42 cm x 60 cm), but mechanical performance accepted by IEC 60601-1. | 650mm x 580mm x 1210mm |
| Weight | Different from predicate (63Kg), but mechanical performance accepted by IEC 60601-1. | 68Kg |
| Safety | ||
| Electrical Safety | Comply with IEC 60601-1, IEC 60601-2-22 (SAME as predicate) | Complies |
| EMC | Comply with IEC 60601-1-2 (SAME as predicate) | Complies |
| Laser Safety | Comply with IEC 60601-2-22, IEC 60825 (SAME as predicate) | Complies |
| Cytotoxicity | No Cytotoxicity (SAME as predicate; aligns with ISO 10993-5) | No Cytotoxicity |
| Sensitization | No evidence of sensitization (SAME as predicate; aligns with ISO 10993-10) | No evidence of sensitization |
| Irritation | No evidence of irritation (SAME as predicate; aligns with ISO 10993-23) | No evidence of irritation |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No clinical study is included in this submission."
Therefore, there is no "test set" in the context of clinical performance data. The evaluation relies on non-clinical (bench) testing and comparison to predicate devices, not human subject data.
Since no clinical study was conducted, there is no data provenance (country of origin, retrospective/prospective) for a test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As no clinical study was conducted and no clinical test set was used, there was no ground truth for a test set established by experts.
4. Adjudication Method for the Test Set
Not applicable. As no clinical study was conducted and no clinical test set was used, there was no adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states: "No clinical study is included in this submission." Therefore, no MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a hardware product (Diode Laser Hair Removal System), not an algorithm or software-only device. Therefore, the concept of "standalone algorithm performance" as typically applied to AI/software as a medical device (SaMD) is not applicable here. The performance is evaluated based on its physical/electrical characteristics and safety standards.
7. The Type of Ground Truth Used
For the non-clinical tests regarding electrical safety, EMC, laser safety, and biocompatibility, the "ground truth" is defined by compliance with internationally recognized standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22, ISO 10993 series). The device's performance is measured against the requirements of these standards.
8. The Sample Size for the Training Set
Not applicable. This is a hardware device submission, not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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.
-
- 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: +86 13581869234 Fax: +86 58497698 Email: alex@mbt-laser.com
-
- Designated Submission Correspondent
Mr. Ray Wang
- Designated Submission Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, 102401, China
Tel: +86-18910677558 Fax: +86-10-56335780 Email: information@believe-med.com
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-
- Identification of Proposed Device
Trade Name: Diode Laser Hair Removal System Common Name: Powered Laser Surgical Instrument Model(s): MBT-Diode Laser
- Identification of Proposed Device
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 DeviceK211335 | Reference DeviceK200525 | Remark |
| Device Name | Diode Laser HairRemoval System | Diode LaserMachine | Diode LaserMachine | / |
| ClassificationRegulation | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | SAME |
| ClassificationPanel | General & PlasticSurgery | General & PlasticSurgery | General & PlasticSurgery | SAME |
| Class | II | II | II | SAME |
| Product Code | GEX | GEX | GEX | SAME |
| Indication for use | The Diode Laser HairRemoval System is intendedfor hair removal, permanent hairreduction on all skintypes (Fitzpatrick skintype I-VI), includingtanned skin.Permanent hairreduction is definedas the long-term,stable reduction inthe number of hairsregrowing whenmeasured at 6, 9, and12 months after thecompletion of atreatment regime. | The Diode LaserMachineModel:BM-100is intendedfor hair removal, permanent hairreduction on all skintypes (Fitzpatrick skintype I-VI), includingtanned skin.Permanent hairreduction is defined asthe long-term, stablereduction in thenumber of hairsregrowing whenmeasured at 6, 9, and12 months after thecompletion of atreatment regime. | The Medical DiodeLaser HairRemoval System isused forpermanent reductionin hairregrowth defined as along term,stable reduction in thenumber ofhairs re-growingwhen measured at6, 9 and 12 monthsafter thecompletion of atreatment regimen.Use on all skin types( FitzpatrickI-VI), includingtanned skin. | SAME |
Table 7-1 General Comparison
Table 7-2 Performance Comparison
| ITEM | Proposed Device | Predicate DeviceK211335 | Reference DeviceK200525 | Remark |
|---|---|---|---|---|
| Laser Type | Diode Laser | Diode Laser | Diode Laser | SAME |
| LaserClassification | 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 | 220/110VAC/50Hz-60Hz | 220/110VAC/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 DeviceK211335 | 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, IEC60825 | 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
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
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-
- 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.
- Substantially Equivalent (SE) Conclusion
§ 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.