(74 days)
Not Found
No
The description focuses on the physical principles of laser hair removal and does not mention any AI or ML components.
No.
The intended use of the device is "hair removal, permanent hair reduction", which is considered an aesthetic or cosmetic procedure, not a therapeutic one that treats a disease or medical condition.
No
The device is intended for hair removal and permanent hair reduction, which are therapeutic applications, not diagnostic. It uses laser energy to target hair follicles rather than to identify or analyze a medical condition.
No
The device description explicitly details hardware components such as a semiconductor diode laser source, a handpiece, and a foot-switch, indicating it is a physical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Diode Laser Therapy Device described is used for hair removal and permanent hair reduction by applying laser energy directly to the skin. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states hair removal and permanent hair reduction, which are therapeutic/cosmetic procedures, not diagnostic tests.
- Device Description: The description details the mechanism of action based on selective photothermolysis and the application of laser energy to the skin, not the analysis of biological samples.
Therefore, based on the provided information, this device falls under the category of a therapeutic or cosmetic medical device, not an In Vitro Diagnostic.
N/A
# Intended Use / Indications for Use
The Diode Laser Therapy Device (Model: DF-DIODE LASER-S1) 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
Diode Laser Therapy Device adopts semi-conductor laser, based on selective photothermolysis principle, through specific wavelength, penetrate epidermis, 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 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
Hospital (for the 'Where used' comparison item in Table 1)
# 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
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
- ♪ 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
- 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
# 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: 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
- 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
No clinical study is included in this submission.
# Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
# Predicate Device(s)
[K211335](https://510k.innolitics.com/search/K211335)
# 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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 13, 2024
WeiFang Dragonfly Electronics Technology Co., Ltd % Rav 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: K241547
Trade/Device Name: Diode Laser Therapy Device (DF-DIODE LASER-S1) 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: May 31, 2024 Received: May 31, 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 (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 (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/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@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Digitally signed by TANISHA TANISHA I HITHE -L. HITHE -S Date: 2024.08.13
17:12:25 -04'00'
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) K241547
Device Name
Diode Laser Therapy Device (Model: DF-DIODE LASER-S1)
Indications for Use (Describe)
The Diode Laser Therapy Device (Model: DF-DIODE LASER-S1) 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) | |
|---|---|
| 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
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: 07/25/2024
-
- Sponsor
WeiFang Dragonfly Electronics Technology Co., Ltd
South side of the second floor, Production workshop No.1, No. 13426 Yuqing East Street, Weifang High-tech Zone, Weifang City Shandong Province, P, R, China Postal Code: 261061 Contact Person: Ray Zhao Position: General Manger Tel: +86-15165606680 Email: df(@df-beauty.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
4. Proposed Device Identification
Trade Name: Diode Laser Therapy Device Common Name: Powered Laser Surgical Instrument Model(s): DF-DIODE LASER-S1
Regulatory Information: Classification Name: Powered Laser Surgical Instrument Classification: II
5
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
Indication For Use Statement:
The Diode Laser Therapy Device (Model: DF-DIODE LASER-S1) 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 Therapy Device adopts semi-conductor laser, based on selective photothermolysis principle, through specific wavelength, penetrate epidermis, 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 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.
Predicate Device Identification 6.
Predicate Device:
510(k) Number: K211335 Product Name: Diode Laser Machine Manufacturer: Zhengzhou Bestview St 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 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
-
- Clinical Test Conclusion
No clinical study is included in this submission.
9. Substantially Equivalent (SE) Comparison
| ITEM | Proposed Device | Predicate Device (K211335) | Remark |
|---|---|---|---|
| Product Code | GEX | GEX | SAME |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | SAME |
| Class | 2 | 2 | SAME |
| Where used | Hospital | Hospital | SAME |
| Indications for use | The Diode Laser Therapy Device (Model: | ||
| DF-DIODE LASER-S1) 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 Machine (Model: | ||
| BM-100) 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 | ||
| Handpiece | Main Unit | ||
| Handpiece | SAME | ||
| Principle of | |||
| Operation | Diode Laser | Diode Laser | SAME |
Table 1 General Comparison
Table 2 Performance Comparison
7
| ITEM | Proposed Device | Predicate Device (K211335) | Remark |
|---|---|---|---|
| Laser Type | Diode Laser | Diode Laser | SAME |
| Laser | |||
| Classification | Class IV | Class IV | SAME |
| Laser wavelength | 808 nm | 808 nm | SAME |
| Spot Size | 2.25cm² (15mm ×15mm) | 2.25cm² (15mm ×15mm) | SAME |
| Fluence | 1-120J/cm² | 0-120J/cm² | SAME |
| Frequency | 1-10 Hz | 1-10Hz | SAME |
| Pulse Duration | 10-400ms | 10-400ms | SAME |
| Power Supply | 100-240VAC, 50/60 Hz | 220/110VAC/50-60Hz | Analysis |
| Dimension | 127×68×54cm | 112cm×42cm×60cm | Analysis |
| Weight | 49kg | 63kg | Analysis |
Analysis:
The proposed device is different in Power Supply, Dimension and Weight from the predicate device. However, these difference are just in physical specification and these 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, these difference will not affect safety and effectiveness of the proposed device.
| ITEM | Proposed Device | Predicate Device (K211335) | Remark |
|---|---|---|---|
| EMC, Electrical and Laser Safety | |||
| Electrical Safety | Comply with IEC 60601-1, | ||
| IEC 60601-2-22 | Comply with IEC 60601-1, | ||
| IEC 60601-2-22 | SAME | ||
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SAME |
| Laser Safety | Comply with IEC 60601-2-22, | ||
| IEC 60825 | Comply with IEC 60601-2-22, | ||
| IEC 60825 | SAME | ||
| Patient Direct/Indirect Contact Materials and Biocompatibility | |||
| Patient | |||
| Direct/Indirect | |||
| Contact Materials | Handpiece | ||
| (Gemstone and Anodized | |||
| aluminum oxide) | Handpiece | Analysis | |
| 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 3 Safety Comparison
Analysis:
The proposed device is different in Patient Direct/Indirect Contact Materials from the predicate device. 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.
8
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 (K211335).