(54 days)
The Diode laser therapy system is intended for 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 proposed device, Diode laser therapy system, is a surgical device. It utilizes a semiconductor diode as a laser source (808nm). The laser power is delivered to the treatment area via a laser handle. The emission laser is activated by handle and footswitch linkage.
The treatment can be applied on different Fitzpatrick skin type, including I (White), II (White with pigment), III (Yellow), IV (Yellow with pigment), V (Brown) and VI (Black).
The provided text describes a 510(k) submission for a medical device, the "Diode laser therapy system," which is intended for permanent hair reduction.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
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A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria and reported device performance in the way a diagnostic AI would have with metrics like sensitivity, specificity, or AUC. Instead, the "acceptance criteria" are implied by the comparison to a predicate device (K210168, Diode Laser Therapy Systems by Beijing Kes Biology Technology CO., LTD.) and compliance with relevant non-clinical standards.
The "performance" is primarily demonstrated through this substantial equivalence comparison and through non-clinical testing.
Here's a summation of the comparison table provided, which implicitly serves as the performance assessment against the predicate:
Item Acceptance Criteria (Predicate K210168) Reported Device Performance (Proposed Device K212978) Remark Product Code GEX GEX Same Regulation No. 21 CFR 878.4810 21 CFR 878.4810 Same Class II II Same Indications for Use Permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Defined as long-term, stable reduction in hair regrowing at 6, 9, and 12 months after treatment. Permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Defined as long-term, stable reduction in hair regrowing at 6, 9, and 12 months after treatment. Same Configuration Main Unit, Handpiece, Foot Control Main Unit, Handle, Foot Control Same Laser Type Diode Laser Diode Laser Same Laser Classification Class IV Class IV Same Laser Wavelength 808 nm 808 nm Same Spot Size 12 mm × 12 mm = 1.44 cm² 1.2 cm × 2.4 cm = 2.88 cm² Different Fluence 10-125 J/cm² 10-120 J/cm² Different Frequency 1-10 Hz 1-10 Hz Same Pulse Duration 10-400 ms 10-300 ms Different Power Supply 99V-121V, 50/60Hz, 1400VA AC 100~230V/50/60Hz, 2000VA Different Dimension 450 × 430 × 1000 mm 430 × 500 × 1030 mm Different Weight 52 kg 65 kg Different Patient contact material Aluminum alloy, ABS Aluminum alloy, Sapphire Different Cytotoxicity No Cytotoxicity (Comply with ISO 10993-5:2009) No Cytotoxicity (Tested according to ISO 10993-5:2009) Same Sensitization No evidence of Sensitization (Comply with ISO 10993-10:2010) No evidence of Sensitization (Tested according to ISO 10993-10:2010) Same Irritation No evidence of Irritation (Comply with ISO 10993-10:2010) No evidence of Irritation (Tested according to ISO 10993-10:2010) Same Electrical Safety Comply with ANSI/AAMI ES60601-1:2005, IEC 60601-2-22 Comply with ANSI/AAMI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and A2:2010/(R) 2012 and IEC 60601-2-22:2012, IEC 60825-1:2014 Same EMC Comply with IEC 60601-1-2 Comply with IEC 60601-1-2:2014 Same Software Validation & Verif N/A (implied by predicate clearance) Software verification & validation conducted as per FDA guidance for "Moderate" level of concern. N/A (New test) Explanation for "Different" remarks: The document states that despite the differences, non-clinical tests were conducted to demonstrate that these differences do not affect the safety and effectiveness of the proposed device. For example:
- Spot Size: Non-clinical tests were done, and the results show the proposed device meets requirements.
- Fluence: The proposed device's fluence range is within the predicate's range.
- Pulse Duration: The proposed device's pulse duration range can be covered by the predicate's range.
- Power Supply: Electrical safety and EMC tests were conducted, and the device works normally.
- Dimension and Weight: These are physical specifications and do not raise safety/effectiveness issues.
- Patient contact material: Biocompatibility tests met ISO 10993 requirements.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document explicitly states: "No clinical study is included in this submission."
Therefore, there is no clinical test set, sample size, or data provenance related to clinical performance. The evaluation is based on non-clinical testing and substantial equivalence to a predicate device. -
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)
Since no clinical study was performed, there was no clinical "test set" and thus no experts or ground truth established for clinical performance as would be the case for a diagnostic AI device.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set or human interpretation was involved.
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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
Not applicable. The device is a laser therapy system, not a diagnostic AI system that assists human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical laser therapy system, not a standalone AI algorithm. It operates as a medical instrument for treatment.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" or reference was compliance with international standards (e.g., ISO 10993 for biocompatibility, IEC 60601 series for electrical safety and electromagnetic compatibility, IEC 60825-1 for laser safety) and demonstrating that parameter differences did not negatively impact safety and effectiveness compared to the predicate.
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The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set in the conventional sense. The "training" for such a device would be its design and manufacturing process to meet specifications and standards.
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How the ground truth for the training set was established
Not applicable for the same reason as above.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 10, 2021
BEIJING UNT Technology Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 China
Re: K212978
Trade/Device Name: Diode laser therapy system 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: August 28, 2021 Received: September 17, 2021
Dear Diana Hong:
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 and Part 809); 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.
Purva Pandya 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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Indications for Use
510(k) Number (if known) K212978
Device Name Diode laser therapy system
Indications for Use (Describe)
The Diode laser therapy system is intended for 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 is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K212978
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- Date of Preparation: 10/27/2021
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- Sponsor Identification
BEIJING UNT Technology Co., Ltd.
M2-1 Area, Xinggu Development Zone, Pinggu District, Beijing, China 101200
Contact Person: Qianwen Sheng Position: Deputy General Manager of Technology Tel: +86-10-61960002 Email: shengqianwen@untlaser.com
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- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jinlei Tang (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd. P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
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Identification of Proposed Device 4.
Trade Name: Diode laser therapy system Common Name: Powered Laser Surgical Instrument Model: Alpha
Regulatory Information
Classification Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Classification: II;
Product Code: GEX; Regulation Number: 21 CFR 878.4810 Review Panel: General & Plastic Surgery;
Indications for use:
The Diode laser therapy 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.
Device Description:
The proposed device, Diode laser therapy system, is a surgical device. It utilizes a semiconductor diode as a laser source (808nm). The laser power is delivered to the treatment area via a laser handle. The emission laser is activated by handle and footswitch linkage.
The treatment can be applied on different Fitzpatrick skin type, including I (White), II (White with pigment), III (Yellow), IV (Yellow with pigment), V (Brown) and VI (Black).
న. Identification of Predicate Device
510K Number: K210168 Trade Name: Diode Laser Therapy Systems Manufacturer: Beijing Kes Biology Technology CO., LTD.
6. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was
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same or similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ISO 10993-5:2009 Biological Evaluation of Medical Device, Part 5-Tests for Vitro Cytotoxicity. >
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ISO 10993-10: 2010 Biological Evaluation of Medical Device, Part 10-Test for irritation and skin sensitization.
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ANSI/AAMI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and A2:2010/ (R) 2012 Medical electrical equipment - Part1: General requirements for basic safety and essential performance
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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.
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IEC 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements.
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IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Software Validation & Verification Testing
Software verification & validation testing were conducted and documentation was provided as recommended by FDA s Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern, since a failure or latent flaw in the software could directly result in erroneous diagnosis or a delay in delivery of appropriate medical care, which could result in minor injury.
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- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
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| Item | Proposed Device K212978 | Predicate Device K210168 | Remark |
|---|---|---|---|
| Product Code | GEX | GEX | Same |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Class | II | II | Same |
| Indications for Use | The Diode laser therapy system isintended for hair removal permanenthair reduction on all skin types(Fitzpatrick skin type I-VI), includingtanned skin.Permanent hair reduction is defined asthe long-term, stable reduction in thenumber of hairs regrowing whenmeasured at 6, 9, and 12 months afterthe completion of a treatment regime. | The Diode Laser Therapy Systems areintended for hair removal permanenthair reduction on all skin types(Fitzpatrick skin type I-VI), includingtanned skin.Permanent hair reduction is defined asthe long-term, stable reduction in thenumber of hairs regrowing whenmeasured at 6, 9, and 12 months afterthe completion of a treatment regime. | Same |
| Configuration | Main UnitHandleFoot Control | Main UnitHandpieceFoot Control | Same |
| Laser Type | Diode Laser | Diode Laser | Same |
| LaserClassification | Class IV | Class IV | Same |
| Laser Wavelength | 808 nm | 808 nm | Same |
| Spot Size | $1.2 cm×2.4 cm=2.88 cm^2$ | $12 mm×12 mm=1.44 cm^2$ | Different |
| Fluence | 10-120 J/cm² | 10-125 J/cm² | Different |
| Frequency | 1-10 Hz | 1-10 Hz | Same |
| Pulse Duration | 10-300 ms | 10-400 ms | Different |
| Power Supply | AC 100~230V/50/60Hz2000VA | 99V-121V, 50/60Hz1400VA | Different |
| Dimension | 430×500×1030mm | 450×430×1000mm | Different |
| Weight | 65kg | 52kg | Different |
| Patient contactmaterial | Aluminum alloy, Sapphire | Aluminum alloy, ABS | Different |
| 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 |
| Electrical Safety | Comply withIEC 60601-1 | Comply withIEC 60601-1 | Same |
| Table 1. Comparison of Technology Characteristics | ||||
|---|---|---|---|---|
| --------------------------------------------------- | -- | -- | -- | -- |
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| IEC 60601-2-22IEC 60825-1 | IEC 60601-2-22IEC 60825-1 | ||
|---|---|---|---|
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same |
Different - Spot Size
The spot size for the proposed device is different from the predicate device. However, non-clinical tests about the spot size have been conducted on the proposed device and the results show that the proposed device meets the requirements. Therefore, this difference will not affect safety and effectiveness of the proposed device.
Different - Fluence
The fluence for the proposed device is different from the predicate device. However, the fluence of the proposed device is within the range of that 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. Therefore, this difference will not affect safety and effectiveness of the proposed device.
Different - Pulse Duration
The pulse duration for the proposed device is different from the predicate device. However, the pulse duration range for the proposed device can be covered in the range of predicate device. Therefore, this difference will not affect safety and effectiveness of the proposed device.
Different - Power Supply
The power supply for the proposed device is different from the predicate device. However, electrical safety and EMC test has been conducted on the proposed device and the test result show that the device can work normally under this power supply. Therefore, this difference will not affect safety and effectiveness of the proposed device.
Different - Dimension and Weight
The dimension and weight for the proposed device is different 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. Therefore, this difference will not affectiveness of the proposed device.
Different - Patient contact material
The patient contact material for the proposed device is different from the predicate device. However, biocompatibility test has been conducted on the proposed device and the test result can meet the requirements of ISO 10993 series standard. Therefore, this difference will not affect safety and effectiveness of the proposed device.
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9. Conclusion
Based on the comparison and analysis above, the proposed device is as safe, as effective, and perform as well as the legally marketed predicate 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.