(54 days)
Not Found
No
The summary describes a standard diode laser system for hair reduction and does not mention any AI or ML components or capabilities.
No
The device is described as a "surgical device" intended for "hair reduction," which is typically considered an aesthetic or cosmetic procedure, not a therapeutic one. Although "therapeutic" is mentioned in one of the standards it complies with, its explicit intended use does not align with a therapeutic purpose.
No
The device is described as a "laser therapy system" intended for "hair reduction." Its function is to perform a therapeutic or cosmetic procedure, not to diagnose a medical condition.
No
The device description explicitly states it is a "surgical device" that "utilizes a semiconductor diode as a laser source" and delivers power via a "laser handle," indicating it is a hardware device with a software component, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "hair reduction on all skin types". This is a therapeutic/cosmetic procedure performed directly on the patient's body.
- Device Description: The device is described as a "surgical device" that utilizes a laser to treat the skin.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests on samples.
The information provided clearly indicates this is a device for external, direct treatment of the patient, not for analyzing samples in a laboratory setting.
N/A
Intended Use / Indications for Use
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.
Product codes
GEX
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).
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
No clinical study is included in this submission.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was 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.
- ISO 10993-10: 2010 Biological Evaluation of Medical Device, Part 10-Test for irritation and skin sensitization.
- 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
- 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 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements.
- 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 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.
Key Metrics
Not Found
Predicate Device(s)
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.
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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
-
- Date of Preparation: 10/27/2021
-
- 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
-
- 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. >
-
ISO 10993-10: 2010 Biological Evaluation of Medical Device, Part 10-Test for irritation and skin sensitization.
-
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
-
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 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements.
-
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.
-
- 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 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 Therapy Systems are
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
Handle
Foot Control | Main Unit
Handpiece
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 | $1.2 cm×2.4 cm=2.88 cm^2$ | $12 mm×12 mm=1.44 cm^2$ | 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/50/60Hz
2000VA | 99V-121V, 50/60Hz
1400VA | Different |
| Dimension | 430×500×1030mm | 450×430×1000mm | Different |
| Weight | 65kg | 52kg | Different |
| Patient contact
material | 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 with
IEC 60601-1 | Comply with
IEC 60601-1 | Same |
| Table 1. Comparison of Technology Characteristics | ||||
|---|---|---|---|---|
| --------------------------------------------------- | -- | -- | -- | -- |
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| | IEC 60601-2-22
IEC 60825-1 | IEC 60601-2-22
IEC 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.