(174 days)
Not Found
No
The description focuses on the physical principles of laser hair removal and standard electrical/laser safety standards. There is no mention of AI, ML, image processing, or data-driven performance metrics.
No
The device is intended for hair removal and permanent hair reduction, which are generally considered cosmetic procedures rather than therapeutic treatments for a disease, injury, or other medical condition.
No
The device's intended use is hair removal and permanent hair reduction, which are treatment purposes, not diagnostic. It does not mention analyzing or detecting medical conditions.
No
The device description clearly details hardware components, including a semiconductor diode laser source, a handpiece, and a foot-switch, indicating it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for hair removal and permanent hair reduction. This is a therapeutic/cosmetic application performed directly on the patient's body.
- Device Description: The device uses a laser to interact with melanin in hair follicles. This is a physical interaction with the patient's tissue.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Diode laser Treatment System (Model: K18) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term. stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
Diode laser Treatment System adopts Gold standard 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 Diode laser Treatment 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
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:
- 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 A 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
- IEC TR 60601-4-2: 2016 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 18, 2024
Hebei Keylaser Sci-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: K241498
Trade/Device Name: Diode laser Treatment System (K18) 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: October 18, 2024 Received: October 18, 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/ofdocs/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.
1
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 (OS) 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 820.70) 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.
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 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-device-advicecomprehensive-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-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).
2
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@;tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
TANISHA L. HITHE -S
Digitally signed by TANISHA L. HITHE -S Date: 2024.11.18 14:24:52 -05'00'
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
3
Indications for Use
Submission Number (if known)
Device Name
Diode laser Treatment System (K18)
Indications for Use (Describe)
The Diode laser Treatment System (Model: K18) 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)
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4
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: K241498
-
- Date of Preparation: 11/15/2024
-
- Sponsor
HEBEI KEYLASER SCI-TECH Co.,Ltd
4th Floor Building C18-2, HeGu Industry Park, Chaoyang East Road, ZhuoZhou Baoding City HeBei Province 072750, China Contact Person: Zhen Yang Position: Chief Executive Officer Tel: +86-18611920156 Email: Thomas@key-laser.com
-
- 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
-
- Proposed Device Identification
Trade Name: Diode laser Treatment System Common Name: Powered Laser Surgical Instrument Model(s): K18
- Proposed Device Identification
Regulatory Information: Classification Name: Powered Laser Surgical Instrument Classification: II Product Code: GEX
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 Diode laser Treatment System (Model: K18) 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
Diode laser Treatment System adopts Gold standard 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 Diode laser Treatment 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:
- A IEC 60601-1: 2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
6
-
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 A 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
- A 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
- A IEC TR 60601-4-2: 2016 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Substantially Equivalent (SE) Comparison 9.
| ITEM | Proposed Device | 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 Diode laser Treatment System
(Model: K18) 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 |
Table 1 General Comparison
7
| Foot Control | Foot Control | SAME | |
|---|---|---|---|
| Principle of | |||
| Operation | Diode Laser | Diode Laser | SAME |
| Laser Type | Diode Laser | Diode Laser | SAME |
| Laser | |||
| Classification | Class IV | Class IV | SAME |
| Laser wavelength | 808 nm | 808 nm | SAME |
| Spot Size | 12mm×24mm | 12.6mm×20.6mm | Analysis 1 |
| Fluence | 1-70J/cm2 | 1-70J/cm2 | SAME |
| Frequency | 1-10 Hz | 1-10Hz | SAME |
| Pulse Duration | 3-320ms | 3-320ms | SAME |
| Power Supply | AC 110V, 50Hz/60Hz | AC 120V/60Hz | Analysis 2 |
| Dimension | 460×370×1150mm | 393mm×430mm×1130mm | Analysis 2 |
| Weight | 52kg | 48kg | Analysis 2 |
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 is different in Dimension and Weight from the predicate device. However, the 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.
| ITEM | Proposed Device | Predicate Device (K221312)
Model: M-I-X MEDICAL | Remark |
|----------------------------------------------------------------|--------------------------------------------|----------------------------------------------------|------------|
| EMC, Electrical and Laser Safety | | | |
| Electrical Safety | Comply with IEC 60601-1,
IEC 60601-2-22 | Comply with ANSI/AAMI ES60601-1,
IEC 60601-2-22 | Analysis 3 |
| 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 | Gemstone | Tip of Handle
(6063 Aluminum & S1 Quartz) | Analysis 4 |
| 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 2 Test Comparison
Page 4 of 5
8
| Biocompatibility
testing standards | Comply with ISO 10993-5,
ISO 10993-10, ISO 10993-23 | Comply with ISO 10993-5,
ISO 10993-10 | Analysis 3 |
| --------------------------------------- | -------------------------------------------------------- | ------------------------------------------ | ------------ |
|---|
Analysis 3:
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 4
The subject and predicate device have different Patient Direct/Indirect Contact Materials, the contact material of the subject device is gemstone. By complying with ISO 10993-5, ISO 10993-10, ISO 10993-23, 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 the legally marketed device (K221312).