(108 days)
No
The summary does not mention AI, ML, deep learning, neural networks, or any related terms. The device description focuses on the laser technology and its application for hair reduction.
No.
The device is intended for hair reduction, which is a cosmetic procedure, not a therapeutic one aimed at treating a disease or condition. The device description also classifies it as a "surgical device".
No
The device is intended for hair reduction, which is a therapeutic or cosmetic purpose, not for diagnosing a condition or disease.
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 handpiece," indicating it is a hardware-based device.
Based on the provided information, 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.
- Anatomical Site: The treatment is applied to "different parts of the body".
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition or provide information about a patient's health status.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Diode Laser Therapy Systems are 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 (comma separated list FDA assigned to the subject device)
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 handpiece. The emission laser is activated by a footswitch.
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); in addition, the treatment can also be applied to different parts of the body, such as arm, chest, leg, underarm etc.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arm, chest, leg, underarm etc.
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 (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:
- 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
May 10, 2021
Beijing Kes Biology Technology CO., LTD. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd P.O.box 120-119 Shanghai, 200120 China
Re: K210168
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: March 30, 2021 Received: April 2, 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.
1
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.
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
2
Indications for Use
510(k) Number (if known)
K210168
Device Name Diode Laser Therapy Systems
Indications for Use (Describe)
The Diode Laser Therapy Systems are 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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3
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: K210168
-
- Date of Preparation: 3/30/2021
-
- Sponsor Identification
BEIJING KES BIOLOGY TECHNOLOGY CO., LTD.
No.15, Zone 2, Mafang Industrial Park, PingguyuanZhongguancun Science And Technology Park Pinggu District, Beijing CHINA 101204
Establishment Registration Number: 3009444646
Contact Person: Wei Meng Meng Position: QS Specialist Tel: +86-10-60998698 Fax: +86-10-61227575 Email: weimengmeng@keslaser.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (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
4
4. Identification of Proposed Device
Trade Name: Diode Laser Therapy Systems Common Name: Powered Laser Surgical Instrument
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:
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.
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 handpiece. The emission laser is activated by a footswitch.
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); in addition, the treatment can also be applied to different parts of the body, such as arm, chest, leg, underarm etc.
-
રું ર Identification of Predicate Device
510(k) Number: K180353 Product Name: Diode laser hair removal device -
б. Identification of Reference Device
Reference Device 1 510K Number: K182924 Trade Name: Diode Laser Treatment System
5
Manufacturer: Weifang KM Electronics Co., Ltd.
Reference Device 2 510K Number: K193426 Trade Name: Elite iQ™ Manufacturer: Cynosure, LLC
Note: The Elite iQTM including two models, 755nm and 1064nm. The 755nm of Elite iQM was selected as reference 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
-
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.
-
A 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
-
Clinical Test Conclusion 8.
No clinical study is included in this submission.
6
9. Substantially Equivalent (SE) Comparison
| ITEM | Proposed Device | Predicate Device | Reference Device 1 | Reference Device 2 |
|---|---|---|---|---|
| Product Code | GEX | K180353 | K182924 | K193426 |
| Regulation | ||||
| No. | GEX | GEX | GEX | GEX |
| 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | |
| Class | II | II | II | II |
| Indication for | ||||
| Use | The Diode Laser Therapy | |||
| Systems are intended for hair | ||||
| removal permanent hair | ||||
| reduction on all skin types | ||||
| (Fitzpatrick skin type IVI), | ||||
| 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. | The Diode Laser Treatment | |||
| 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 Elite iQ Laser System is indicated | |||
| for stable long-term or permanent hair | ||||
| reduction. Permanent hair reduction is | ||||
| defined as long-term stable reduction in | ||||
| the number of hairs regrowing when | ||||
| measured at 6, 9 or 12 months after the | ||||
| completion of a treatment regime. It is | ||||
| used for skin types (Fitzpatrick I-VI) | ||||
| including tanned skin. It is also | ||||
| indicated for the treatment of vascular | ||||
| lesions, benign pigmented lesions, and | ||||
| wrinkles. | ||||
| Configuration | Main Unit | Main Unit | Main Unit | Main Unit |
| Handpiece | Handpiece | Handpiece | Handpiece | |
| Foot Control | Foot Control | / | Foot Control and Finger Control | |
| Laser Type | Diode Laser | Diode Laser | Diode Laser | Alexandrite |
| Laser | Class IV | Class IV | Class IV | Unknown |
| Classification | ||||
| Laser | ||||
| Wavelength | 808 nm | 808 nm | 808nm | 755nm |
| Spot Size | 12 mm×12 mm=1.44 cm² | 1.44 cm² | 1.44 cm² | 2.5mm, 5mm, 7mm, 10mm, 12mm, |
| 15mm, 18mm, 20mm, 22mm, & 24mm | ||||
| Fluence | 10-125 J/cm² | 1-100 J/ cm² | 2-120 J/ cm² | Up to 600J/ cm² |
| Frequency | 1-10 Hz | 1-20 Hz | 1-10Hz | 0.5~10Hz |
| Pulse | ||||
| Duration | 10-400 ms | 10-400 ms | 10-300ms | 0.5~300ms |
| Power Supply | 99V-121V, 50/60Hz | |||
| 1400VA | AC 110V-230V/50-60Hz | |||
| 2000VA | 100-240V AC, 50/60Hz | 208V | ||
| 5500VA | ||||
| Dimension | 450×430×1000mm | 560×380×1180mm | 600×420×380mm | |
| 600×420×350mm | ||||
| 600×420×400mm | ||||
| 550×420×300mm | Unknown | |||
| Weight | 52kg | 60 Kg | 35Kg | Unknown |
| Patient | ||||
| Contacting | ||||
| Material | Aluminum alloy, ABS | Sapphire in handpiece | Sapphire in handpiece and | |
| handpiece tip (stainless steel) | 316 Stainless Steel | |||
| Biocompatibility | ||||
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | No Cytotoxicity | Comply with ISO 10993-1 |
| Sensitization | No evidence of Sensitization | No evidence of Sensitization | Comply with ISO 10993-1 | Comply with ISO 10993-1 |
| Irritation | No evidence of Irritation | No evidence of Irritation | Comply with ISO 10993-1 | Comply with ISO 10993-1 |
| Electrical Safety and EMC | ||||
| Electrical | ||||
| Safety | Comply with | |||
| IEC 60601-1 | ||||
| IEC 60601-2-22 | Comply with | |||
| IEC 60601-1 | ||||
| IEC 60601-2-22 | Comply with | |||
| IEC 60601-1 | ||||
| IEC 60601-2-22 | Comply with | |||
| IEC 60601-1 | ||||
| IEC 60601-2-22 | ||||
| IEC 60825-1 | IEC 60825-1 | IEC 60825-1 | IEC 60825-1 | |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 |
Table 1 Comparison of Technology Characteristics
7
510(k) Summary
8
510(k) Summary
- Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device.