(87 days)
Not Found
No
The document describes a medical diode laser system for hair removal operating on the principle of selective photothermolysis. It does not mention any components or functionalities related to Artificial Intelligence, Machine Learning, Deep Neural Networks, or image processing.
No
The device is intended for hair removal, which is generally considered a cosmetic procedure, not a therapeutic treatment for a disease or medical condition.
No
This device is a hair removal system that uses a laser to target hair follicles. Its intended use is for hair removal and permanent hair reduction, which are therapeutic and aesthetic procedures, not diagnostic ones.
No
The device is a hardware-based medical device because the description explicitly states it is a "Medical Diode Laser Hair Removal System" that "adopts 808nm semi-conductor laser" and utilizes a "laser handpiece" and "foot-switch" for operation. These are all physical hardware components.
No.
The device is a laser hair removal system, which acts on hair follicles for cosmetic and aesthetic purposes, not for in vitro examination of specimens derived from the human body.
No.
The letter explicitly states "Not Found" under the "Predetermined Change Control Plan (PCCP) - All Relevant Information" section, indicating that it is not a PCCP authorized device.
Intended Use / Indications for Use
The Medical 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.
Product codes
GEX
Device Description
Medical Diode Laser Hair Removal System adopts 808nm semi-conductor laser, based on selective photothermolysis principle, through specific wavelength, penetrate epidermis into dermis, optical energy was absorbed and translated into heat energy with restraining hair follicle tissues, and produce photothermal effect. It takes laser energy in hair follicle with rich in melanin, surrounding tissues absorb less even no energy, reach to restrained melanin of hair follicles and remove hair. The Medical Diode Laser Hair Removal System 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 handpiece. The emission laser is activated by a foot-switch.
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
Prescription Use
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:
- IEC 60601-1: 2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2: 2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- 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
- IEC 60825-1: 2007 Safety of laser products - Part 1: Equipment classification, and requirements
- ISO 10993-5: 2009 Biological evaluation of medical device - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10: 2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
- ISO 10993-23: 2021 Biological evaluation of medical devices - Part 23: Tests for irritation
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 12, 2025
Shandong Moonlight Electronics Tech 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: K250431
Trade/Device Name: Medical Diode Laser Hair Removal System (MNLT-D1)
Regulation Number: 21 CFR 878.4810
Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology
Regulatory Class: Class II
Product Code: GEX
Dated: February 14, 2025
Received: February 14, 2025
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.
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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K250431 - Ray Wang
Page 2
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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K250431 - Ray Wang
Page 3
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,
YAN FU -S Digitally signed by YAN FU -S
Date: 2025.05.12 16:40:48 -04'00'
for 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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K250431
Device Name
Medical Diode Laser Hair Removal System (MNLT-D1)
Indications for Use (Describe)
The Medical 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.
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
PRAStaff@fda.hhs.gov
"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."
Page 5
Premarket Notification 510(k) Submission - 510(k) Summary
Page 1 of 5
510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
The assigned 510(k) Number: K250431
1. Date of Preparation: 04/03/2025
2. Sponsor
Shandong Moonlight Electronics Tech Co.,Ltd.
NO.30, LECHUAN, XINHUA ROAD, ECONOMIC DEVELOPMENT ZONE, WEIFANG, SHANDONG, CHINA.
Contact Person: Jvqiang Xin
Position: General Manager
Tel: +86-15689898388
Email: ng585858@126.com
3. Submission Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, China, 102401
Contact Person: Ray Wang
Position: General Manager
Tel: +86-18910677558
Fax: +86-10-56335780
Email: information@believe-med.com
4. Proposed Device Identification
Trade Name: Medical Diode Laser Hair Removal System
Common Name: Powered Laser Surgical Instrument
Model(s): MNLT-D1
Regulatory Information:
Classification Name: Powered Laser Surgical Instrument
Classification: II
Product Code: GEX
Page 6
Premarket Notification 510(k) Submission - 510(k) Summary
Page 2 of 5
Regulation Number: 21 CFR 878.4810
Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology
Review Panel: General & Plastic Surgery
Indication For Use Statement:
The Medical 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.
5. Device Description
Medical Diode Laser Hair Removal System adopts 808nm semi-conductor laser, based on selective photothermolysis principle, through specific wavelength, penetrate epidermis into dermis, optical energy was absorbed and translated into heat energy with restraining hair follicle tissues, and produce photothermal effect. It takes laser energy in hair follicle with rich in melanin, surrounding tissues absorb less even no energy, reach to restrained melanin of hair follicles and remove hair. The Medical Diode Laser Hair Removal System 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 handpiece. The emission laser is activated by a foot-switch.
6. Predicate Device Identification
Predicate Device:
510(k) Number: K221312
Product Name: Diode Laser Hair Removal Device
Model: M-I-X MEDICAL
Manufacturer: Guangzhou CHUANG ZAO MEI Technology Co., Ltd
7. 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 complies with the following standards:
- IEC 60601-1: 2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
Page 7
Premarket Notification 510(k) Submission - 510(k) Summary
Page 3 of 5
- IEC 60601-1-2: 2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- 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
- IEC 60825-1: 2007 Safety of laser products - Part 1: Equipment classification, and requirements
- ISO 10993-5: 2009 Biological evaluation of medical device - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10: 2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
- ISO 10993-23: 2021 Biological evaluation of medical devices - Part 23: Tests for irritation
8. Clinical Test Conclusion
No clinical study is included in this submission.
9. Substantially Equivalent (SE) Comparison
Table 1 General Comparison
| ITEM | Proposed Device Model: MNLT-D1 | Predicate Device (K221312) Model: M-I-X MEDICAL | Remark |
|---|---|---|---|
| Product Code | GEX | GEX | SAME |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | SAME |
| Class | 2 | 2 | SAME |
| Indications for use | The Medical 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 Hair Removal Device (Model: EVOLUTION MEDICAL, M-I-X MEDICAL) 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. | SAME |
| Configuration | Main Unit | Main Unit | SAME |
| Handpiece | Handpiece | SAME | |
| Foot Control | Foot Control | SAME | |
| Principle of Operation | Diode Laser | Diode Laser | SAME |
Page 8
Premarket Notification 510(k) Submission - 510(k) Summary
Page 4 of 5
| Laser Type | Diode Laser | Diode Laser | SAME |
|---|---|---|---|
| Laser Classification | Class IV | Class IV | SAME |
| Laser wavelength | 808 nm | 808 nm | SAME |
| Spot Size | 12mm × 21mm | 12.6mm × 20.6mm | Analysis 1 |
| Fluence | 1-65J/cm² | 1-70J/cm² | Analysis 2 |
| Frequency | 1-10 Hz | 1-10Hz | SAME |
| Pulse Duration | 10-320ms | 3-320ms | Analysis 3 |
| Power Supply | AC 110V, 50Hz/60Hz | AC 120V/60Hz | Analysis 4 |
| Dimension | 1180×465×465mm | 393mm×430mm×1130mm | Analysis 4 |
| Weight | 74kg | 48kg | Analysis 4 |
Analysis 1:
The proposed device is different in Spot Size from the predicate, Spot size only affects the area of treatment, not affect the therapeutic effect. Therefore, this difference will not affect the safety and effectiveness.
Analysis 2:
The proposed device only has slight difference in Fluence with the predicate device. The fluence of the proposed device is within the allowable error range of the predicate device, which can justify that the difference in the parameter of fluence will not raise new safety issues of the proposed device. And the bench tests conducted on the proposed device is same with the predicate device, the results of which could support the substantially equivalency with predicate device. So the slight difference is considered to have no effect on effectiveness and safety.
Analysis 3:
The proposed device is difference in Pulse Duration with the predicate device. The pulse duration of the proposed device is within the range of that of the predicate device, which is similar to the proposed device's pulse duration, so this difference will not affect safety and effectiveness of the proposed device.
Analysis 4:
The proposed device is different in Power Supply, Dimension and Weight from the predicate device. However, the power supply, dimension and weight difference are just in physical specification and this difference will not raise any issues in safety and effectiveness. By complying with IEC 60601-1, the mechanical performance of the proposed device is determined to be accepted. Therefore, this difference will not affect safety and effectiveness of the proposed device.
Table 2 Test Comparison
| ITEM | Proposed Device | Predicate Device (K221312) Model: M-I-X MEDICAL | Remark |
|---|---|---|---|
| EMC, Electrical and Laser Safety |
Page 9
Premarket Notification 510(k) Submission - 510(k) Summary
Page 5 of 5
| Electrical Safety | Comply with IEC 60601-1, IEC 60601-2-22 | Comply with ANSI/AAMI ES60601-1, IEC 60601-2-22 | Analysis 5 |
|---|---|---|---|
| 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 Direct/Indirect Contact Materials and Biocompatibility
| Patient Direct/Indirect Contact Materials | Aluminum and Gemstone | Tip of Handle (6063 Aluminum & S1 Quartz) | Analysis 6 |
|---|---|---|---|
| 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 |
| Biocompatibility testing standards | Comply with ISO 10993-5, ISO 10993-10, ISO 10993-23 | Comply with ISO 10993-5, ISO 10993-10 | Analysis 5 |
Analysis 5:
The proposed device is different in Electrical Safety Testing Standard and Biocompatibility Testing Standard from the predicate device. The proposed device was tested according to IEC 60601-1:2020, ISO 10993-5:2009, ISO 10993-10:2021 and ISO 10993-23:2021, which are FDA recognized standard. Therefore, this different will not affect safety and effectiveness of the proposed device.
Analysis 6:
The subject and predicate device have different Patient Direct/Indirect Contact Materials, the contact material of the subject device is aluminum and gemstone. By complying with ISO 10993-5, ISO 10993-10, ISO10993-23, the material of proposed device is determined to be accepted. Therefore, this different will not affect safety and effectiveness of the proposed device.
10. Substantially Equivalent (SE) Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device (K221312).