(52 days)
No
The summary describes a standard diode laser system for hair removal and does not mention any AI or ML components or functionalities.
Yes.
The device is intended for hair removal and permanent hair reduction, which are medical purposes, and it uses a laser, a form of energy, to achieve these effects.
No
The device's "Intended Use / Indications for Use" states it is "intended for hair removal, permanent hair reduction," which is a treatment, not a diagnosis.
No
The device description clearly outlines hardware components like 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:
- Intended Use: The intended use is for hair removal and permanent hair reduction. This is a therapeutic/cosmetic application performed directly on the patient's body.
- Device Description: The device is a laser system that emits infrared radiation to target melanin in hair follicles. This is a physical interaction with the body, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Dermatological Diode Laser Systems(Model: CM01D/CM02D) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-V), including tanned 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 Dermatological Diode Laser 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 s laser handpiece. The emission laser is activated by a foot-switch.
There are 2 models included,CM01D,CM02D, the two models have same mechanism of action, principle and specification, only difference is the configuration. The detailed difference shown as following:
| CM01D | CM02D | |
|---|---|---|
| Display | 15.6" color touch LCD screen | 4.3" color touch LCD screen |
| Treatment laser spot | 10×30 mm | 9× 12 mm |
| Pulse width | 15-400 ms (continuously adjustable ) | 35-400 ms ( continuously adjustable ) |
| Energy density | 05-100J/ cm2 (continuously adjustable | 03-30J/ cm2 ( continuously adjustable ) |
| Pulse frequency | 1-10Hz | 1-3Hz |
| Size | 635246cm | 4944139cm |
| Weight | 75Kg | 3Kg |
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 (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 to be as safe, as effective, and perform as well as the legally marketed predicate devices.. The test results demonstrated that the proposed device complies with the following standards:
- ES60601-1:2005+A1:2012 Medical Electrical Equipment - Part 1: General AAMI Requirements for Safety And Essential Performance
- IEC 60601-2-22:2007 + A1:2012, 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. 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 - Electromagnetic Compatibility
- ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity
- ISO 10993-10:2002/Amd. 1: 2006, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity AMENDMENT 1
- Software Validation & Verification Test
According to "guidance for the content of premarket submissions for software contained in medical devices" issued by FDA, software verification and validation activities were carried out. Verification and validation activities include the verification and validation of product function, product performance and product interface. All verification and validation activities can meet the specified requirements, and the product software is safe and effective.
No clinical study is included in this submission.
Key results: Based on the comparison and analysis, the proposed device is determined to be as safe, as effective, and performs as well as the legally marketed predicate devices.
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.
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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.
April 26, 2021
Beijing HuaCheng Taike Technology Co., Ltd. % Hui Liu Official Correspondent Beijing Believe Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, Beijing 102401 China
Re: K210663
Trade/Device Name: Dermatological Diode Laser 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: February 27, 2021 Received: March 5, 2021
Dear Hui Liu:
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 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) K210663
Device Name
Dermatological Diode Laser Systems
Indications for Use (Describe)
The Dermatological Diode Laser Systems(Model: CM01D/CM02D) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-V), including tanned 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 of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K210663
-
- Date of Preparation
04/15/2021
- Date of Preparation
-
- Sponsor
Beijing HuaCheng Taike Technology Co., Ltd.
5102P,Floor1,Building5,No.17Yunshannanlu Road, Tongzhou Industrial Development Zone,Tongzhou district, 101113 Beijing, P.R. China Contact Person: Li Yi Position: General Manager Tel: +86 15810861388 Fax: +8610 61592593 Email: alex@cosmedplus.com
- Submission Correspondent 3.
Contact Person:
Mr. Ray Wang(Primary)
Tel: +86-18910677558
Fax: +86-10-52214696
Email: ray.wang@believe-med.com
Ms. Hui Liu (Secondary) Tel: +86-15922145259 Fax: +86-10-52214696 Email: hui.liu@believe-med.com
Beijing Believe Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, China,102401
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-
- Identification of Proposed Device
Trade Name: Dermatological Diode Laser Systems Common Name: Powered Laser Surgical Instrument Model(s): CM01D/CM02D
- Identification of Proposed Device
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;
Indication For Use:
The Dermatological Diode Laser Systems(Model:CM01D/CM02D) 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 న్.
The Dermatological Diode Laser 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 s laser handpiece. The emission laser is activated by a foot-switch.
There are 2 models included,CM01D,CM02D, the two models have same mechanism of action, principle and specification, only difference is the configuration. The detailed difference shown as following:
| CM01D | CM02D | |
|---|---|---|
| Display | 15.6" color touch LCD screen | 4.3" color touch LCD screen |
| Treatment laser spot | 10×30 mm | 9× 12 mm |
| Pulse width | 15-400 ms (continuously adjustable ) | 35-400 ms ( continuously adjustable ) |
| Energy density | 05-100J/ cm2 (continuously adjustable | 03-30J/ cm2 ( continuously adjustable ) |
| Pulse frequency | 1-10Hz | 1-3Hz |
| Size | 635246cm | 4944139cm |
| Weight | 75Kg | 3Kg |
Table 1 The Difference of Models
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-
- Identification of Predicate Device
Predicate Device 510(k) Number: K180353 Product Name: Diode Laser Hair Removal Device Manufacturer: Zhengzhou PZ Laser Slim Technology Co., Ltd
- Identification of Predicate Device
Reference Device 510(k) Number: K142845 Product Name: SILKPRO Laser Hair Removal System Manufacturer: Wuhan Lotuxs Technology Company, Ltd.
-
- Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was to be as safe, as effective, and perform as well as the legally marketed predicate devices.. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
-
ES60601-1:2005+A1:2012 Medical Electrical Equipment - Part 1: General AAMI Requirements for Safety And Essential Performance
-
IEC 60601-2-22:2007 + A1:2012, 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. 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 - Electromagnetic Compatibility
-
ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity
-
ISO 10993-10:2002/Amd. 1: 2006, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity AMENDMENT 1
-
Software Validation & Verification Test
According to "guidance for the content of premarket submissions for software contained in medical devices" issued by FDA, software verification and validation activities were carried out. Verification and validation activities include the verification and validation of product function, product performance and product interface. All verification and validation activities can meet the specified requirements, and the product software is safe and effective.
-
Clinical Test Conclusion 8.
No clinical study is included in this submission. -
Comparison with Predicate and Reference Devices 9.
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Table 2 General Comparison
| ITEM | Proposed Device | Predicate Device (K180353) | Reference Device (K142845) | Remark |
|---|---|---|---|---|
| Product Code | GEX | GEX | OHT | Same |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Class | 2 | 2 | 2 | Same |
| Indication For Use | The Dermatological Diode Laser Systems(Model:CM01D/CM02D) 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. | SILKPRO is an over-thecounter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. SILKPRO is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime. | Same |
| Configuration | Main Unit | Main Unit | / | Same |
| Handpiece | Handpiece | / | Same | |
| Foot Control | Foot Control | / | Same | |
| Principle of | ||||
| Operation | Diode Laser | Diode Laser | Diode Laser | Same |
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| ITEM | Proposed Device | Predicate Device (K180353) | Reference Device (K142845) | Remark |
|---|---|---|---|---|
| Laser Type | Diode Laser | Diode Laser | Diode Laser | Same |
| Laser | ||||
| Classification | Class IV | Class IV | Class IV | Same |
| Laser | ||||
| wavelength | 808 nm | 808 nm | 810 nm | Same |
| Spot Size | CM01D:10 × 30 mm | |||
| CM02D:9× 12 mm | $1.44 cm^2$ | 9mm×9mm (0.81cm²) | Analysis | |
| Fluence | CM01D:5-100J/ cm2 | |||
| CM02D:03-30J/ cm2 | 1-100J/ cm2 | 5-25J/cm2 | Analysis 2 | |
| Frequency | CM01D: 1 - 10 Hz; | |||
| CM02D: 1 - 3 Hz | 1-20Hz | / | Analysis5 | |
| Pulse Duration | CM01D:15-400 ms | |||
| CM02D:35-400 ms | 10-400ms | / | Similar | |
| Power Supply | AC 110V/60Hz | AC 110V/60Hz | AC100~240V, 50/60Hz | Same |
| Dimension | CM01D:65cmX65cmX123cm | |||
| CM02D:253mm210mm193mm | 560mm x 380mm x1 180mm | / | Analysis | |
| Weight | CM01D:75KG | |||
| CM02D:3kg | 60kg | Analysis |
Table 3 Performance Comparison
Analysis 1
The proposed device is different in Spot Size from the predicate, Spot size only affects the area of treatment, not affect the therapeutic effect.Therefore, this difference will not affect the safety and effectiveness.
Analysis 2
The proposed device is different in fluence from the predicate device, the difference is very slight. Fluence of the proposed device is within the range of the predicate and reference devices.And the proposed device has passed the IEC60601-1 test, IEC60601-1-2 test, IEC60601-2-22 test ,IEC60825-1 test, the safety and performance of the product can be ensured. So the proposed device is determined to be as safe, as effective, and performs as well as the legally marketed predicate devices.
Analysis 3/ 4
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 safety and effectiveness.
Analysis 5
The proposed device is different in Frequency from the predicate device, the frequency is the number of times light is emitted in a second. The Frequency of the proposed device is within the range of the
8
predicate device.And the proposed device has passed the IEC60601-1 test, IEC60601-1-2 test, IEC60601-2-22 test ,IEC60825-1 test, the safety and performance of the product can be ensured. therefore, this difference will not affect the safety and effectiveness.
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| Item | Proposed Device | Predicate Device (K180353) | Reference Device (K142845) | Remark |
|---|---|---|---|---|
| EMC, Electrical and Laser Safety | ||||
| 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 | Same |
| EMC | Comply with IEC 60601-1-2 | 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 | Comply with IEC 60601-2-22, IEC 60825 | Same |
| Patient Direct/Indirect Contact Materials and Biocompatibility | ||||
| Patient | ||||
| Direct/Indirect | ||||
| Contact Materials | Tip of Handle (6061 Aluminium &Quartz ) | |||
| Device Housing (Acrylonitrile Butadiene | ||||
| Styrene) | Sapphire in handpiece | Stainless steel and Sapphire in | ||
| handpiece | Analysis6 | |||
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | Comply with ISO 10993-1 | Same |
| Sensitization | No evidence of sensitization | No evidence of sensitization | ||
| Irritation | No evidence of irritation | No evidence of irritation |
Table 4 Safety Comparison
Analysis 6:
The proposed device is different in Patient Indirect Contact Materials from the predicate device, to confirm that the components and materials contained in the finished device as identified above are not adverse to human tissue, the biocompatibility testing was performed in accordance with ISO 10993-1: 2009 and guidance document entitled Blue Book Memo, G95-1, Use of International Standard ISO-10993, and Biological Evaluation of Medical Devices: Part 1: Evaluation and Testing.The results for the biocompatibility testing showed that there are no negative impacts from the materials that are used in the proposed device, therefore, this difference will not affect the safety and effectiveness.
10. Conclusion
Based on the comparison and analysis above, the proposed device is determined to be as safe, as effective, and performs as well as the legally marketed predicate devices.