(52 days)
Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Standard-A) is intended for hair removal permanent hair reduction on all 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 Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) is solution for fast hair removal with 810nm±10nm high power laser diodes. They are designed with TEC and sapphire cooling unit for skin contact. The laser beam is sublimated with a patented technology of beam shaping for a high efficiency for hair removal solution. This diode laser hair removal can be used for Fitzpatrick skin type I-VI. The pulse energy is up to 40J/cm².
The provided text describes the acceptance criteria and study proving the device's substantial equivalence to predicate devices, focusing on technical and safety aspects rather than clinical performance data with specific acceptance criteria related to a clinical outcome.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of clinical acceptance criteria. Instead, it demonstrates substantial equivalence to predicate devices by comparing technical specifications and adherence to safety and performance standards. The "performance" reported is primarily the device's compliance with these standards and its technical similarity to the predicates.
| Acceptance Criteria (Implied from Comparisons & Standards) | Reported Device Performance |
|---|---|
| Safety and Essential Performance (General) | Complies with AAMI/ANSI ES60601-1:2005(R) 2012 and A1:2012 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance). |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2:2014. |
| Biocompatibility (Cytotoxicity) | Complies with ISO 10993-5:2009 (Tests for in vitro cytotoxicity). |
| Biocompatibility (Irritation & Skin Sensitization) | Complies with ISO 10993-10:2010 (Tests for irritation and skin sensitization). |
| Laser Product Safety (General) | Complies with IEC 60825-1:2014 (Safety of laser products - Part 1: Equipment classification and requirements). |
| Laser Product Safety (Surgical/Cosmetic) | Complies with IEC 60601-2-22:2019 (Particular requirements for the safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment). |
| Software Validation | Complies with FDA Final Guidance-General Principles of Software Validation and IEC62304-2015. Level of Concern classified as Moderate LOC; validation confirmed no unacceptable risk. |
| Risk Management | Complies with ISO10993-1 Fifth edition 2018-08 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management). |
| System Operation | Met specified requirements (bench testing). |
| Wavelength | Met specified requirements and is similar to predicate devices (810nm nominal, similar to 808nm and 810nm nominal of predicates). Slight difference (808nm vs 810nm) deemed not to affect safety or clinical effectiveness based on absorption curves. |
| Single Pulse Laser Energy | Met specified requirements. |
| Repetition Frequency | Met specified requirements and is similar to predicate devices (1-10 Hz vs. 5-10 Hz/0.5-3 Hz and 1-10 Hz). |
| Laser Power Output | Met specified requirements. |
| Cooling Parameters | Met specified requirements. Employs Sapphire Contact and TEC Cooling, comparable to predicate and deemed to improve safety. |
| Fluence | 1-40 J/cm², lower than predicates (2-120 J/cm² and 10-125 J/cm²), implying "safety is better." |
| Pulse Duration | 3-160 ms, smaller than predicates (3.3-200 ms and 10-400 ms), implying "safety is better." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes bench testing and compliance with various standards, not a clinical study with a "test set" of patient data or a specific sample size of subjects. The verification tests were performed on the device itself.
Therefore, there is no mention of a "sample size" for a test set in the clinical sense, nor data provenance like country of origin or retrospective/prospective status as it pertains to human subjects.
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)
This information is not provided as the device's clearance is based on technical performance and safety standards, not on a clinical performance study requiring expert ground truth in diagnostics or treatment outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided because the submission focuses on technical specifications, safety, and substantial equivalence to predicate devices, not a clinical trial with a test set requiring adjudication of findings.
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
This is not applicable. The device is a "Diode Laser Hair Removal Systems for Medical Use." It is a treatment device, not an AI-powered diagnostic tool used by human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical laser system for hair removal. While it contains software, the "standalone" performance described in the context of AI algorithms is not relevant here. The software plays a role in the user interface and system control, validated according to general software principles.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is compliance with established international and national safety and performance standards for medical electrical equipment, laser products, and biocompatibility (e.g., IEC 60601 series, IEC 60825-1, ISO 10993 series). The functional aspects (wavelength, energy, frequency, cooling) were verified through bench testing against specified requirements. For the software, the "ground truth" was established by validating it against FDA Final Guidance-General Principles of Software Validation and IEC62304-2015 to ensure it does not raise unacceptable risks.
8. The sample size for the training set
This is not applicable/provided. The submission does not describe an AI model or machine learning algorithm that requires a "training set" of data in the typical sense. The software validation refers to the software embedded within the device, not a separate AI algorithm trained on a dataset.
9. How the ground truth for the training set was established
This is not applicable/provided as there is no mention of an AI training set in the document.
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November 7, 2022
Sanhe Laserconn Tech Co., Ltd. % Gary Wang Q&R Consultant Bonnier Quality Supervision Consulting (JM) Center Hailunxinyuan No.3203, Jianghai District Jiangmen, Guangdong 529000 China
Re: K222800
Trade/Device Name: Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) 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: September 8, 2022 Received: September 16, 2022
Dear Gary 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 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.
Jianting Wang -S
Jianting Wang Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K22800
Device Name
Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A)
Indications for Use (Describe)
Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Standard-A) is intended for hair removal permanent hair reduction on all 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) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
--- Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Date: 10-21-2022 (M/D/Y)
the following summary of information is provided: In accordance to 21 CFR 807.92 regulation,
| I Applicant/Manufacturer | Sanhe Laserconn Tech Co., Ltd.X03-A Building, Baishijingu Industry Park, Yanjiao,Langfang, Hebei, China 065201 |
|---|---|
| Contact Person | Miss Xia aijiangPhone: (+86) 15726687295E-mail: xiaaijian@laserconn.com |
| II Submitter/Correspondent | Bonnier Quality Supervision Consulting (JM) CenterHailunxinyuan No.3203, Jianghai District, Jiangmen CityChina 529000 |
| Contact Person | Mr. Gary WangQ&R ConsultantPhone: (+86)13600366215E-mail: gary.wang@bonnier.net.cn |
III Device Regulation Information
| Common Name of Device: | Powered Laser Surgical Instrument |
|---|---|
| Classification panel: | General & Plastic Surgery |
| Classification Names: | Laser Surgical Instrument for Use in General and Plastic |
| Surgery and In Dermatology | |
| Regulation Number: | 21 CFR 878.4810 |
| Regulation Class: | II |
| Product Code: | GEX |
| Type of 510(k) submission: | Traditional 510(k) |
| Model Name/Number | Milestone Smart-M, Milestone Standard-A |
| Device Trade Name | Diode Laser Hair Removal Systems for Medical Use(Models: Milestone Smart-M, Milestone Standard-A) |
IV Predicate Device Information
Predicate Device 1 Sponsor: Device Name:
510(K) Number: Predicate Device 2
Alma Lasers, Inc. SOPRANO ICE MULTI-APPLICATION & MULTI-TECHNOLOGY PLATFORM K140009
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Sponsor: Device Name: 510(K) Number:
Beijing Kes Biology Technology CO., LTD. Diode laser therapy system K210168
V Device Description
Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) is solution for fast hair removal with 810nm±10nm high power laser diodes. They are designed with TEC and sapphire cooling unit for skin contact. The laser beam is sublimated with a patented technology of beam shaping for a high efficiency for hair removal solution. This diode laser hair removal can be used for Fitzpatrick skin type I-VI. The pulse energy is up to 40J/cm².
VI Indications for Use
Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) 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.
VII Compatibility
Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) does not connect with any other device and does not connect network during normal operation. So will not cause any problem related to compatibility with other device and network. For EMC, the devices were tested according to IEC 60601-1-2:2014.
VIII Technological Comparison
Pls refer to the later part: Substantial Equivalence Comparison Table 1
IX Software
Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) includes software which are interface between operator and device. The risk analysis and control to software is done, the Level of Concern is classified as Moderate LOC. The validation to software is done according to FDA Final Guidance-General Principles of Software Validation and confirm the software does not raise unacceptable risk by Sanhe Laserconn Tech Co., Ltd.
X. Summary of Verification Tests
All verification tests have been performed according to below standard, the testing results are passed
1.AAMI/ANSI ES60601-1:2005(R) 2012 and A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
2.IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
3.ISO 10993-5:2009: Biological evaluation of medical devices. Part 5-Tests for in vitro cytotoxicity.
4.ISO 10993-10:2010 Biological evaluation of medical devices, Part 10-Tests for irritation and skin sensitization.
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5.IEC 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements.
6.IEC 60601-2-22:2019 for use in conjunction with AAMI/ANSI ES60601-1:2005(R) 2012 and A1:2012
Medical electrical equipment - Part 2-22: Particular requirements for the safety and essential
performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
- Software embedded in medical device was validated by the least burdensome approach according to FDA Final Guidance-General Principles of Software Validation.
8.IEC62304-2015 Medical device software – Software life cycle processes
9.ISO10993-1 Fifth edition 2018-08 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management
Bench testing was conducted to demonstrate that system operation, wavelength, single pulse laser energy, repetition frequency, laser power output, and cooling parameters met specified requirements. The test results also show that both models Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) have achieved the expected results and satisfied the standards listed above.
XI.Conclusion:
Based on the SE comparison and software validation result, Sanhe Laserconn Tech Co., Ltd. considers Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) does not raise any new issues of safety or effectiveness, and performs as well as the legally marketed predicate device.
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| Substantial Equivalence Comparison Table 1 | Discussion | |||
|---|---|---|---|---|
| Description | Predicate Device 1 | Predicate Device 2 | Subject Device | |
| K number | K140009 | K210168 | K222800 | |
| Device name | SOPRANO ICE MULTI-APPLICATION &MULTI-TECHNOLOGY PLATFORM | Diode laser therapy system | Diode Laser Hair Removal Systems forMedical Use (Models: Milestone Smart-M,Milestone Standard-A) | |
| Manufacturer | Alma Lasers, Inc. | Beijing Kes Biology Technology CO.,LTD. | Sanhe Laserconn Tech Co., Ltd. | |
| Prescription | Yes | Yes | Yes | Same |
| Over-the-Counter use | No | No | No | Same |
| Product Code | GEX | GEX | GEX | Same |
| Configuration | Main console Unit | Main Unit | Main Unit | Same |
| Modules | Handle | Handle | Same | |
| Laser Type | Diode Laser | Diode Laser | Diode Laser | Same |
| Laser Classification | Class IV | Class IV | Class IV | Same |
| Regulatory Class | Class II | Class II | Class II | Same |
| Wavelength | 810nm(nominal) | 808nm(nominal) | 810nm(nominal) | Discussion 1 |
| Spot Size | $12 mm\times10 mm=1.2 cm2$ | $12 mm\times12 mm=1.44 cm2$ | $10 mm\times10 mm=1.0 cm2$ | Discussion 2 |
| Fluence | 2-20 J/cm2 (SHR), 2-120 J/cm2 (HR) | 10-125 J/cm2 | 1-40 J/cm2 | Discussion 3 |
| Pulse Duration | 3.3-200 ms | 10-400 ms | 3-160 ms | Discussion 4 |
| Frequency | 5-10 Hz (SHR), 0.5-3 Hz (HR) | 1-10 Hz | 1-10 Hz | Discussion 5 |
| Tissue Cooling | Contact continuous, thermo-electrical | Aluminum contact, close-cycle water cooling | Sapphire Contact and TEC Cooling | Discussion 6 |
| Power Supply | Unknown | 99V-121V, 50/60Hz 1400VA | AC 100~240V/50/60Hz 1500VA | Discussion7 |
| Biocompatibility | Unknown | Comply with ISO 10993-5, ISO 10993-10 | Comply with ISO 10993-5 ISO 10993-10 | Discussion 8 |
| Electrical Safety | Comply with IEC 60601-1,IEC 60601-2-22,IEC 60825-1 | Comply with IEC 60601-1,IEC 60601-2-22,IEC 60825-1 | Comply with IEC 60601-1IEC 60601-2-22IEC 60825-1 | Same |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same |
| Storage temperature | Unknown | Unknown | 5°C-55°C | Discussion 9 |
| Operation temperature | Unknown | Unknown | 5°C-30°C | Discussion 11 |
| Operating humidity | Unknown | Unknown | ≤80% | Discussion 12 |
| Dimension | 6.694.81.9 [inches] | 450×430×1000(mm) | 464387979(mm) (Milestone Standard-A)437355233(mm) (Milestone Smart-M) | Discussion 13 |
| Weight | Unknown | 52kg | 46.1kg (Milestone Standard-A)18.2kg (Milestone Smart-M) | Discussion 14 |
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Discussion1: Different - Wavelength
The laser wavelength of this device is the same as K140009 and similar to K210168.
According to" IEC 60825-1:2014 Safety of laser products Part 1: Equipments 700m-1050mm laser is the emission limit of the same group, so the slight wavelength difference between 808nm will not make a difference in laser safety. In addition, the therapeutic effect of laser treatment is caused by the themal effect generated after the skin surface and is absorbed by hair follides However, according to the laser absorpion curve of human to any from 800mm to 850m belongs to the low value of water absorpion and the peak value of pigment absorption. The subtle wavelendth difference between 808mm and 810mm will not have any difference in the penetration depth of laser and the absorption effect of tissues, and will not affect the clinical effectiveness.
Discussion2: Different - Spot Size
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posed device is similar to the predicate device. The output laser energy density is an important factor affecting safety. Therefore, this difference will not affect safety and effectiveness of the proposed device.
Discussion 3: Different - Fluence Laser energy density is low and safety is better.
Discussion 4: Different - Pulse Duration
The pulse width of this instrument is smaller than that of K210168 and K140009, and the single pulse energy is lower, so the safety is better.
Discussion 5: Different - Frequency
The pulse frequency of this instrument is the same as K210168, higher than K140009.
The product of laser repetition frequency and pulse instrument is not more than 100W. For example, when the frequency is 10HZ, the corresponding energy density is 10Jom², which is single pulse energy value of K14009 of 120 J/cm². Therefore, the safety and effectiveness will not be affected.
Discussion 6: Different -Tissue Cooling
Good skin cooling can greatly reduce the probability and serenergy. This device is same as model K14009, the sapphire on the handle tip is cooled by TEC. It's with smaller size, lighter weight, fast cooling result will improve the treatment safety.
Discussion 7: Different - Power Supply
The power supply of the device may be different from the predical safety and EMC test has been conducted on the proposed device and the test result show that the device can work normally under this difference will not affect safety and effectiveness of the proposed device.
Discussion 8-14: The differences from Discussion 8-14 don't affect the safety and performance to medical device.
§ 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.