(74 days)
The US 450 Diode Laser Equipment 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.
US450 Diode Laser Equipment is a device which adopts the high-energy and continuous diode laser to realize the conversion of electricity, light and heat energy, and thus achieves disease treatment. Therefore, this is a laser therapeutic product that integrates laser technology, electronic technology, computer science and medical science.
Under the control of microprocessor, laser power supply can provide the adjustable constant current for the laser module, the high power laser diode in the laser module can transform the electric energy into the light, generate the continuous laser beam with a wavelength of 808mm. Semiconductor laser used for hair removal is mainly based on the principle of selective photothermal action, that is, a specific wavelength of laser can only be selectively absorbed by the target color base.
US450 Diode Laser Equipment consists of power supply system, microprocessor control system, operation display system, cooling system, treatment handle and safety alarm system.
This document is a 510(k) summary for the US 450 Diode Laser Equipment, a device intended for hair reduction. The content focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and performance data from a specific clinical study for an AI/algorithm-based device.
Therefore, many of the requested elements for an AI/algorithm-based device (e.g., sample size for test set with data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable or not available within this document. This submission primarily relies on non-clinical testing and comparison with a predicate device to establish safety and effectiveness.
Here’s an attempt to answer the questions based only on the provided text, indicating when information is not applicable or not present.
Device: US 450 Diode Laser Equipment
Intended Use: 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.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate device (Diode Laser Hair Removal System, Model:M-DL100, K162659) and compliance with relevant safety and performance standards. The "performance" in this context refers to the device's technical specifications and safety profile, rather than a clinical success rate, as no clinical study was conducted for this submission.
Table of Acceptance Criteria and Reported Device "Performance" (Comparison to Predicate Device)
| Feature/Standard | Acceptance Criteria (Implicit - Substantial Equivalence / Standard Compliance) | Reported Device Performance (Proposed Device) | Remark for Equivalence |
|---|---|---|---|
| Classification | 21 CFR 878.4810, Class II, Product Code GEX, General & Plastic Surgery Panel | 21 CFR 878.4810, Class II, Product Code GEX, General & Plastic Surgery Panel | SAME |
| Indication for Use | Hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction defined as long-term, stable reduction in hair regrowing at 6, 9, 12 months post-treatment. Prescription use. | Identical to predicate device. Prescription use. | 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 | 808nm | 808nm | SAME |
| Spot Size | 1.44 cm² (Predicate) | 10x10 mm² (1 cm²) | Different: Noted that it “only relate to the treatment area size, will not affect the effectiveness and safety.” |
| Energy Density | 1-120 J/cm² (Predicate) | 5-80 J/cm² | Different: Proposed device's range is within the predicate's range and its maximum is smaller. Justified by safety tests and comparison to a reference device (K221312) with a lower energy density that is effective. |
| Pulse Frequency | 0.5-15 Hz (Predicate) | 0.5-3 Hz | Different: Proposed device's range is within the predicate's range. Justified by safety and performance tests. |
| Pulse Duration | 5-400 ms | 5-400 ms | SAME |
| Power Supply | AC 110V/60Hz (Predicate) | AC 110V/50/60Hz | Different: Justified by electrical safety and EMC tests. |
| Dimension | 450mm x 550mm x 380mm (Predicate) | 47 x 47 x 132 cm | Different: Justified by compliance with IEC 60601-1 for mechanical performance. |
| Weight | 52 kg (Predicate) | 68 kg | Different: Justified by compliance with IEC 60601-1 for mechanical performance. |
| Electrical Safety | Compliance with IEC 60601-1 | Complies with IEC 60601-1:2005, AMD1:2012 with US National Differences A | SAME |
| EMC | Compliance with IEC 60601-1-2 | Complies with IEC 60601-1-2:2014 | SAME |
| Patient Contact Material | Sapphire in handpiece (Predicate) | Handle head: Aluminum; Ophthalmic Lens: Aluminum oxide | Different: Justified by passing ISO 10993 series tests. |
| Biocompatibility (Cytotoxicity) | No toxicity (ISO 10993-5) | No toxicity (ISO 10993-5) | SAME |
| Biocompatibility (Irritation) | No irritation (ISO 10993-10) | Applied sample did not induce irritation to skin (ISO 10993-10) | SAME |
| Biocompatibility (Sensitization) | No sensitization (ISO 10993-10) | No significant evidence of causing skin sensitization (ISO 10993-10) | SAME |
Study Details (Focusing on the Provided Document)
This document is a 510(k) summary, which inherently focuses on comparing a new device to a legally marketed predicate device to demonstrate substantial equivalence, rather than providing results from a detailed clinical trial or an AI/algorithm performance study.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. The submission explicitly states: "No clinical study is included in this submission." The evaluation relies entirely on non-clinical tests (electrical safety, EMC, biocompatibility, performance tests demonstrating compliance with standards) and comparison 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):
- N/A. As no clinical study or test set with ground truth annotations was conducted or used in this 510(k) submission, this information is not applicable.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No clinical test set.
-
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:
- N/A. This device is a laser hair removal system, not an AI-assisted diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This applies to an AI/algorithm, which this device is not. The "performance test" mentioned for the device itself would be the closest analogue, confirming the laser system's physical output parameters (energy, frequency, etc.) meet specifications and ensure safety and effectiveness.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. No ground truth in the context of clinical interpretation/diagnosis was established for this submission. The "ground truth" for the device's performance is adherence to established engineering standards (e.g., IEC 60601-1, ISO 10993) and the demonstrated technical specifications being within acceptable ranges or justified differences compared to a predicate device with known effectiveness.
- For the intended use of "permanent hair reduction," the definition is provided: "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." However, no new clinical data demonstrating this outcome with the proposed device is provided.
-
The sample size for the training set:
- N/A. This is not an AI/algorithm-based device.
-
How the ground truth for the training set was established:
- N/A. This is not an AI/algorithm-based device.
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December 9, 2022
Beijing Globalipl Development 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, Beijing 102401 China
Re: K222916
Trade/Device Name: US 450 Diode Laser Equipment 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 26, 2022 Received: September 26, 2022
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 (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); 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.
Jianting Wang -S
Jianting Wang Acting 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) K222916
Device Name US 450 Diode Laser Equipment
Indications for Use (Describe)
The US 450 Diode Laser Equipment 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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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The assigned 510(k) Number:
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 Title 21, CFR Section 807.92.
-
- Date of Submission: 2022/12/8
-
- Sponsor Identification
Beijing Globalipl Development Co., Ltd.
F-8 Qunyinghui Building, Jinyuan Rd.32, Daxing Economic Development Zone, Beijing, China 102628
Contact Person: Liu Jun Position: QA Manager Tel: +86-15169727366 Fax: +86-10-60212336 Email: register@globalipl.com
-
- Designated Submission Correspondent
Mr. Ray Wang
- Designated Submission Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, 102401, China
Tel: +86-18910677558 Fax: +86-10-56335780 Email: information@believe-med.com
Identification of Proposed Device 4.
Trade Name: US 450 Diode Laser Equipment
Common Name: Powered Laser Surgical Instrument
Regulatory Information Classification Name: Powered Laser Surgical Instrument Classification: II
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Product Code: GEX Regulation Number: 878.4810 Review Panel: General & Plastic Surgery
-
న్. Identification of Predicate Device(s)
510(k) Number: K162659 Product Name: Diode Laser Hair Removal System (Model:M-DL100) Manufacturer: Shandong Huamei Technology Co.,ltd. -
- Device Description:
US450 Diode Laser Equipment is a device which adopts the high-energy and continuous diode laser to realize the conversion of electricity, light and heat energy, and thus achieves disease treatment. Therefore, this is a laser therapeutic product that integrates laser technology, electronic technology, computer science and medical science.
- Device Description:
Under the control of microprocessor, laser power supply can provide the adjustable constant current for the laser module, the high power laser diode in the laser module can transform the electric energy into the light, generate the continuous laser beam with a wavelength of 808mm. Semiconductor laser used for hair removal is mainly based on the principle of selective photothermal action, that is, a specific wavelength of laser can only be selectively absorbed by the target color base.
US450 Diode Laser Equipment consists of power supply system, microprocessor control system, operation display system, cooling system, treatment handle and safety alarm system.
-
- Indication For Use Statement:
The US 450 Diode Laser Equipment is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.
- Indication For Use Statement:
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.
| Table 8-1 General Comparison | |||
|---|---|---|---|
| Item | Proposed Device | Predicate Device K162659 | Remark |
| Device Name | US 450 Diode Laser Equipment | Diode Laser Hair Removal System(Model:M-DL100) | / |
| ClassificationRegulation | 21 CFR 878.4810 | 21 CFR 878.4810 | SAME |
| ClassificationPanel | General & Plastic Surgery | General & Plastic Surgery | SAME |
| Class | II | II | SAME |
| Product Code | GEX | GEX | SAME |
| Common Name | Powered Laser Surgical Instrument | Powered Laser Surgical Instrument | SAME |
-
- Substantially Equivalent (SE) Comparison
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| Indication for use | The US 450 Diode Laser Equipmentis intended for hair removal,permanent hair reduction on all skintypes (Fitzpatrick skin type I-VI),including tanned skin. | The Diode Laser Hair RemovalSystem is intended for hair removal,permanent hair reduction on all skintypes (Fitzpatrick skin type I-VI),including tanned skin. | SAME | ||
|---|---|---|---|---|---|
| Permanent hair reduction is definedas the long-term, stable reduction inthe number of hairs regrowing whenmeasured at 6, 9, and 12 monthsafter the completion of a treatmentregime. | Permanent hair reduction is definedas the long-term, stable reduction inthe number of hairs regrowing whenmeasured at 6, 9, and 12 monthsafter the completion of a treatmentregime. | ||||
| Prescription useor not | Prescription use | Prescription use | SAME | ||
| Configuration | Main Unit, Handpiece, Foot Control | Main Unit, Handpiece, Foot Control | SAME |
| Table 8-2 Performance Comparison |
|---|
| ITEM | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Principle ofOperation | Diode laser | Diode laser | SAME |
| Laser Type | Diode laser | Diode laser | SAME |
| LaserClassification | Class IV | Class IV | SAME |
| LaserWavelength | 808nm | 808nm | SAME |
| Spot size | $10\times10$ mm² | 1.44 cm² | Different |
| Energy density | 5~80J/cm²(continuouslyadjustable) | 1-120J/cm² | Different |
| Pulse frequency | 0.5-3Hz | 0.5-15Hz | Different |
| Pulse Duration | 5~400ms | 5-400ms | SAME |
1
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| Power Supply | AC 110V50/60Hz | AC 110V/60Hz | Different |
|---|---|---|---|
| Dimension | 47 x 47 x 132cm | 450mm× 550mm×380mm | Different |
| Weight | 68 kg | 52kg | Different |
Analysis:
Different - Spot size
The proposed device has different spot size with the predicate device, which only relate to the treatment area size, will not affect the effectiveness and safety.
Different - Energy density
The proposed device has different Energy density from the predicate device.
Energy density of proposed device is within the predicate device. The greater the energy density, the more energy output, and the greater the risk. The maximum energy density that we can adjust is smaller than the predicate device. And the proposed device has passed the IEC60601-1-2 test, IEC60601-2-22 test, IEC60825-1 test and performance test, the safety of the product can be ensured.
In order to ensure the effectiveness of the product, we have established a reference device K221312, Diode Laser Hair Removal Device (Model:EVOLUTION MEDICAL). It is also a diode laser product which intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Its laser wavelength is also 808nm and its energy density is 1-77 J/cm². We have same intended use with reference device and the energy density of the proposed device is higher than the reference device. The energy output of the reference device is smaller than the proposed device and it can achieve the intended use effectively. We think the effectiveness of the proposed device also can be ensured.
Different - Pulse frequency
The proposed device has different Pulse frequency from the predicate device.
Frequency of proposed device is within the predicate device. And the proposed device has passed the IEC60601-1 test, IEC60601-1-2 test, IEC60601-2-22 test, IEC60825-1 test and performance test, the safety and performance of the product can be ensured.
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.
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Different - Dimension, Weight
The proposed device is different in dimension and weight from the predicate device. By complying with IEC 60601-1, the mechanical performance of the proposed device is determined to be accepted, therefore, this difference of dimension and weight have no effect the effectiveness and safety.
| ITEM | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| ElectricalSafety | The proposed devices weretested to demonstrated tocomply with IEC 60601-1 | The predicate devices weretested to demonstrated tocomply with IEC 60601-1 | SAME |
| EMC | The proposed devices weretested to demonstrated tocomply with IEC 60601-1-2 | The predicate devices weretested to demonstrated tocomply with IEC 60601-1-2 | SAME |
| Patient ContactMaterial | Handle head: AluminumOphthalmic Lens: Aluminiumoxide | Sapphire in handpiece | Different |
| Biocompatibility | |||
| Cytotoxicity | No toxicity (ISO 10993-5) | No toxicity (ISO 10993-5) | SAME |
| Irritation | Applied sample did notinduce irritation to skin. (ISO10993-10) | Applied sample did not induceirritation to skin. (ISO10993-10) | SAME |
| Sensitization | The test article showed nosignification evidence ofcausing skin sensitization inthe guinea pig. (ISO10993-10) | The test article showed nosignification evidence ofcausing skin sensitization in theguinea pig. (ISO 10993-10) | SAME |
| Table 8-3 Safety Comparison |
|---|
Discussion
The proposed device is different in Patient Contact Materials from the predicate device. But the predicate device and the proposed device has passed the ISO10993 series test. We believe that the difference will not affect the effectiveness and safety compared with the predicate device.
-
- 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:
- Non-Clinical Test Conclusion
-
IEC 60601-1:2005, AMD1:2012 with US National Differences A
-
IEC 60601-1-2:2014, Medical Electrical Equipment-Part 1-2: General Requirements For Basic Safety And Essential Performance -Collateral Standard: Electromagnetic
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Compatibility-Requirements And Tests
-
IEC 60825-1:2014, Safety of laser products - Part 1: Equipment classification, and requirements
-
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
- ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro ア Cytotoxicity
-
ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
-
- 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 predicate device Diode Laser Hair Removal System (K162659).
- Conclusion
§ 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.