(86 days)
No
The summary describes a standard diode laser hair removal device based on the principle of selective photothermolysis. There is no mention of AI, ML, image processing, or any data-driven algorithms for treatment planning, parameter adjustment, or outcome prediction. The performance studies focus on compliance with safety and performance standards, not on AI/ML model validation.
No.
The intended use of the device is for hair removal and permanent hair reduction, which are cosmetic procedures, not therapeutic treatments for a disease or medical condition.
No
The device is intended for therapeutic hair removal, not for diagnosing medical conditions.
No
The device description clearly outlines hardware components such as 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 "hair removal, permanent hair reduction". This is a therapeutic/cosmetic procedure performed directly on the patient's body.
- Device Description: The description details a laser device that applies energy to the skin to target hair follicles. This is an external application, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Diode laser therapy device 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 Hair Removal 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. Meanwhile, don't hurt around tissues and virtually pain-free remove surplus hair; eventually, reach to permanent Hair Removal.
The Diode laser therapy device 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:
- A 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
- AAMI/ANSI ES 60601-1: 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-2-22: 2019 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: 2014 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: 2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- ISO 14971: 2019 Medical devices - Application of risk management to medical devices
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.
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.
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Image /page/0/Picture/0 description: The image contains 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 30, 2023
Hebei Zhemai Technology Co., Ltd Ray Wang Official Correspondent 1st FL, N of No.1 Warehouse, W of Shuichang Rd, N of Beiyi Rd. Yanjiao Development Zone, Sanhe Langfang, Hebei 065201 China
Re: K232709
Trade/Device Name: Diode laser therapy device 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 4, 2023 Received: September 5, 2023
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 (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/cdrb/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
1
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 (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 820.30 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 medical devices and radiation-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@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Tanisha L. Tanisha L. Hithe -S 2023.11.30 Hithe -S 16:26:37 -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
510(k) Number (if known)
Device Name Diode laser therapy device
Indications for Use (Describe)
The Diode laser therapy device 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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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 21 CFR 807.92.
The assigned 510(k) Number:
-
- Date of Preparation: 10/31/2023
-
- Sponsor
Hebei Zhemai Technology Co.,Ltd
1st Floor, North of No.1 Warehouse, West of Shuichang Road, North of Beiyi Road, Yanjiao Development Zone, Sanhe, Langfang, Hebei, China, 065201 Contact Person: Yuting Qu Position: Sales Manager Tel: +86-18678802036 Email: feijiakeji(@zoho.com.cn
-
- Submission Correspondent
Contact Person: Ray Wang Tel: +86-18910677558 Fax: +86-10-56335780 Email: information@believe-med.com
- Submission Correspondent
Proposed Device Identification 4.
Trade Name: Diode laser therapy device Common Name: Powered Laser Surgical Instrument Model(s): FD-L01 Regulatory Information: Classification Name: Powered Laser Surgical Instrument Classification: II Product Code: GEX 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
5
Indication For Use Statement:
The Diode laser therapy device 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 Hair Removal 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. Meanwhile, don't hurt around tissues and virtually pain-free remove surplus hair; eventually, reach to permanent Hair Removal.
The Diode laser therapy device 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: K210663 Product Name: Dermatological Diode Laser Systems Model: CM01D Manufacturer: Beijing HuaCheng Taike 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 60601-1-2: 2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
-
AAMI/ANSI ES 60601-1: 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
6
- ♪ IEC 60601-2-22: 2019 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: 2014 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
- A ISO 10993-10: 2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- ♪ ISO 14971: 2019 Medical devices - Application of risk management to medical devices
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Substantially Equivalent (SE) Comparison 9.
| ITEM | Proposed Device | Predicate Device (K210663)
Model: CM01D | Remark |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Code | GEX | GEX | SAME |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | SAME |
| Class | 2 | 2 | SAME |
| Indication for Use | The Diode laser therapy device 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 Dermatological Diode Laser Systems
(Model: CMO2D) 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 |
Table 6-1 General Comparison
Table 6-2 Performance Comparison
| ITEM | Proposed Device | Predicate Device (K210663) | Remark |
|---|---|---|---|
| Model: CM01D | |||
| Laser Type | Diode Laser | Diode Laser | SAME |
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| Laser Classification | Class IV | Class IV | SAME |
|---|---|---|---|
| Laser wavelength | 808 nm | 808 nm | SAME |
| Spot Size | 12mm × 35mm | 10 × 30 mm | Analysis 1 |
| Fluence | 5-100 J/cm² | 5-100J/cm² | SAME |
| Frequency | 1-10 Hz | 1-10Hz | SAME |
| Pulse Duration | 5-200ms | 15-400ms | Analysis 2 |
| Power Supply | AC 110V/60Hz | AC 110V/60Hz | SAME |
| Dimension | 55cm × 55 cm × 123cm | 65cm × 65cm × 123cm | Analysis 3 |
| Weight | 62kg | 75kg | 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 is difference in Pulse Duration with the predicate device. The frequency of the proposed device is within the range of that of the predicate device, which can justify that the difference in the parameter of Pulse duration will not raise new safety issues of the proposed device. In addition, we also found a reference device (K181019), which has the same intended use as the reference device. The Pulse Duration of the reference device is 30-200 ms, which is similar to the proposed device's pulse duration, so this difference will not affect the effectiveness of the device.
In summary, this difference will not affect safety and effectiveness of the proposed device.
Analysis 3/4:
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 AAMI/ANSV/ES 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.
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 (K210663).