(99 days)
No
The description focuses on the physical principles of laser hair removal and does not mention any AI/ML components or capabilities.
No
The device is described as a surgical device primarily intended for hair removal and permanent hair reduction by destroying hair follicles, which is not considered a therapeutic function.
No
The device is described as a "surgical device" intended for "hair removal" and "permanent hair reduction" by destroying hair follicles. This is a therapeutic or cosmetic purpose, not for diagnosing a medical condition.
No
The device description clearly outlines hardware components such as a semiconductor diode, laser source, laser handpiece, and 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:
- 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. These tests are performed outside of the body.
- Device Function: The description clearly states that the Diode Laser Therapy Systems is a surgical device intended for hair removal and permanent hair reduction. It works by applying laser energy directly to the hair follicles on the skin. This is a procedure performed on the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is for a cosmetic/aesthetic procedure (hair removal), not for diagnosing a disease or condition based on analyzing biological samples.
Therefore, the function and intended use of this device fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Diode Laser Therapy Systems 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 Systems is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);
The Diode Laser Therapy Systems 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.
The Diode Laser Therapy Systems utilize the principle of photoepilation for hair removal. The Photoepilation is a technique for removal of unwanted hair by thermal destruction of the hair follicle and its reproductive system (stems cells). The heat is caused by selective absorption of electromagnetic radiation emitted by laser light sources. As melanin is the main chromophore existing in hair follicles, so the melanin could absorb the energy from the laser, which would result in temperature rapid increase, then the hair follicle and its reproductive system (stems cells) would be destroyed by increased high temperature without damage epidermis and the surrounding normal tissue.
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
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: IEC 60601-1-2:2014, IEC 60601- 1:2005+CORR.1:2006+CORR.2:2007+A1:2012, IEC 60601-2-22:2007 + A1:2012 +A2:2019, IEC 60825-1:2014 (Third Edition), ISO 10993-5: 2009, ISO 10993-10: 2010. No clinical study is included in this submission.
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 shows 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 20, 2022
Beijing LaserTell Medical Co., Ltd. Mr. Ray Wang Official Correspondent Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, Beijing 102401 China
Re: K220381
Trade/Device Name: Diode Laser Therapy Systems 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: April 18, 2022 Received: April 22, 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 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). 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220381
Device Name Diode Laser Therapy Systems
Indications for Use (Describe)
The Diode Laser Therapy Systems 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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The assigned 510(k) Number: K220381
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 Preparation:2022/05/18
-
- Sponsor Identification
Beijing LaserTell Medical Co., Ltd.
Block1, No.12 Jingsheng South 2nd Road, JQ Science Park, Tongzhou District, Beijing, China.
Contact Person: Zeng Xun Position: General Manager Tel: +86 13810934930 Fax: +86 10 56370036 Email: alex(@lasertell.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
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4. Identification of Proposed Device
Trade Name: Diode Laser Therapy Systems Common Name: Powered Laser Surgical Instrument Model(s): AlexMED Pro
Regulatory Information: Classification Name: Powered Laser Surgical Instrument Classification: II; Product Code: GEX; Regulation Number: 21 CFR 878.4810; Review Panel: General & Plastic Surgery;
Indication For Use Statement:
The Diode Laser Therapy Systems 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.
న్. Device Description
Diode Laser Therapy Systems is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);
The Diode Laser Therapy Systems 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.
The Diode Laser Therapy Systems utilize the principle of photoepilation for hair removal. The Photoepilation is a technique for removal of unwanted hair by thermal destruction of the hair follicle and its reproductive system (stems cells). The heat is caused by selective absorption of electromagnetic radiation emitted by laser light sources. As melanin is the main chromophore existing in hair follicles, so the melanin could absorb the energy from the laser, which would result in temperature rapid increase, then the hair follicle and its reproductive system (stems cells) would be destroyed by increased high temperature without damage epidermis and the surrounding normal tissue.
-
- Identification of Predicate Device(s)
510(k) Number: K180353 Product Name: Diode Laser Hair Removal Device Manufacturer: Zhengzhou PZ Laser Slim Technology Co., Ltd
- Identification of Predicate Device(s)
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7. Substantially Equivalent (SE) Comparison
| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Device Name | Diode Laser Therapy Systems | Diode Laser Hair Removal / Device | |
| Classification | |||
| Regulation | 21 CFR 878.4810 | 21 CFR 878.4810 | SAME |
| Classification Panel | General & Plastic | ||
| Surgery | General & Plastic | ||
| Surgery | SAME | ||
| Class | II | II | SAME |
| Product Code | GEX | GEX | SAME |
| Indication for use | The Diode Laser Therapy Systems 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 Hair Removal 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. | SAME |
Table 7-1 General Comparison
Table 7-2 Performance Comparison
| ITEM | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Laser Type | Diode Laser | Diode Laser | SAME |
| Laser | |||
| Classification | Class IV | Class IV | SAME |
| Laser | |||
| Wavelength | 808nm±2nm | 808nm | SAME |
| Spot Size | 15mm×15mm | 1.44cm² | Analysis 1 |
| Fluence | 1-100J/cm² | 1-100J/cm² | SAME |
| Frequency | 1-10Hz | 1-20 Hz | Analysis 2 |
| Pulse Duration | 1-300ms | 10~400ms | Analysis 3 |
| Power Supply | 110 Va.c.60Hz | ||
| 2000W | AC 110V-230V/50-60Hz | ||
| 2000VA | Analysis 4 | ||
| Dimension | 460mm×390mm×1230mm | 560mm×380mm×1180mm | Analysis 5 |
| Weight | 75Kg | 60Kg | Analysis 5 |
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Analvsis :
Analysis 1: #Spot size
The proposed device is different in Spot Size from the predicate, Spot size only affects the area of treatment, not affect the therapeutic effect. 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 the substantially equivalency.
Analysis 2: #Frequency
The frequency for the proposed device is different from the predicate device. However, 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 frequency will not raise new safety issues of the proposed device. And the bench tests conducted on the proposed device is same with the predicate device, the results of which could support the substantially equivalency with predicate device.
Analysis 3: #Pulse Duration
The proposed device only has slight 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. So the slight difference is considered to have no effectiveness and safety. And the bench tests conducted on the proposed device is same with the predicate device, the results of which could support the substantially equivalency with predicate device.
Analysis 4: # Power Supply
The Power Supply of proposed device is different with the predicate device, but the proposed device has been conducted as IEC 60601-1 and IEC 60601-1-2, the results shown that, there is no effect the effectiveness and safety.
Analysis 5: #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 will not affect the substantially equivalency.
| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| EMC, Electrical and Laser Safety |
Table 7-3 Safety Comparison
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| 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 Contact Materials and Biocompatibility | |||
| Patient Indirect Contact Materials | Tip of Handle (6061 Aluminum & Sapphire) | ||
| Plastic shell (Acrylonitrile Butadiene Styrene) | Sapphire | Analysis 6 | |
| 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 |
Analysis 6 # Patient Indirect Contact Materials
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.
Non-Clinical Test Conclusion 8.
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:
IEC 60601-1-2:2014 Medical Electrical Equipment-Part 1-2: General Requirements For Basic Safety And Essential Performance Collateral Standard: Electromagnetic Compatibility-Requirements And Tests
IEC 60601- 1:2005+CORR.1:2006+CORR.2:2007+A1:2012 Medical Electrical Equipment - Part 1: General Requirements for Safety
IEC 60601-2-22:2007 + A1:2012 +A2:2019 Medical Electrical Equipment - Part 2: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
IEC 60825-1:2014 (Third Edition) Safety of laser products - Part 1: Equipment classification, and requirements
ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
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9. Clinical Testing
No clinical study is included in this submission.
- Conclusion 10.
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the Diode Laser Therapy Systems (AlexMED Pro) is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Diode Laser Hair Removal Device cleared under K180353.