K Number
K212478
Device Name
Dermatological diode laser system
Date Cleared
2022-01-14

(158 days)

Product Code
Regulation Number
878.4810
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Dermatological diode laser 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 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. The laser light targets on melanin and treat selectively in a precise way. Melanin could absorb the energy from the laser, which would result in temperature rapid increase, to destroy germinal cell and does not damage epidermis and the surrounding normal tissue. After laser exposure, the debris of these cells is removed from the body by phagocytic cells. The four models of different products produced by our company are consistent in Wavelength , Energy Fluence, Pulse Duration, Energy deviation, Spot Size, Frequency and so on. It's just that the shell is slightly different.
More Information

Not Found

No
The summary describes a standard diode laser system for hair removal, focusing on the physical properties of the laser and its interaction with melanin. There is no mention of AI, ML, image processing, or any data-driven decision-making processes within the device description or performance studies.

Yes.
The device is intended for "permanent hair reduction," which is a measurable physiological change, and its description explicitly mentions destroying "germinal cells," indicating a therapeutic effect. Additionally, the device's standards compliance includes IEC 60601-2-22, which covers "Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment."

No

Explanation: The device is intended for hair removal and permanent hair reduction by targeting melanin with a laser, which is a therapeutic rather than diagnostic function. It does not identify or analyze any medical conditions.

No

The device description clearly outlines a hardware-based laser system with a handpiece and foot-switch, not a software-only product.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is clearly stated as "hair removal, permanent hair reduction". This is a therapeutic/cosmetic procedure performed directly on the patient's body.
  • Device Description: The device description details a laser system that emits light to target melanin in hair follicles. This is a physical interaction with the patient's tissue.
  • Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. This device does not involve the analysis of any biological samples.

The device described is a therapeutic laser device used for a cosmetic/medical procedure performed in vivo (on the living body).

N/A

Intended Use / Indications for Use

The Dermatological diode laser 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.

Product codes

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.

The laser light targets on melanin and treat selectively in a precise way. Melanin could absorb the energy from the laser, which would result in temperature rapid increase, to destroy germinal cell and does not damage epidermis and the surrounding normal tissue. After laser exposure, the debris of these cells is removed from the body by phagocytic cells.

The four models of different products produced by our company are consistent in Wavelength , Energy Fluence, Pulse Duration, Energy deviation, Spot Size, Frequency and so on. It's just that the shell is slightly different.

ADPL2ALD1DPL4LD1
Wavelength808nm±10nm808nm±10nm808nm±10nm808nm±10nm
Energy Fluence1-120J/cm²(Adjustable)1-120J/cm²(Adjustable)1-120J/cm²(Adjustable)1-120J/cm²(Adjustable)
Pulse Duration10-400 ms10-400 ms10-400 ms10-400 ms
Energy deviation±20%±20%±20%±20%
Spot Size12*12mm12*12mm12*12mm12*12mm
Frequency1-10Hz1-10Hz1-10Hz1-10Hz

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

Prescription Use

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:

  • AAMI ES60601-1:2005+A1:2012 Medical Electrical Equipment - Part 1: General Requirements for Safety and Essential Performance;
  • IEC 60601-2-22:2007, 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: 2007, Safety of laser products - Part 1: Equipment classification and requirements.
  • IEC 60601-1-2:2007, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests.
  • 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
  • Performance Testing for Spot Size Accuracy and Energy Output Accuracy.
  • Software Validation & Verification Test

No clinical study is included in this submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K162659

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.

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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 14, 2022

Beijing Stelle Laser Technology 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: K212478

Trade/Device Name: Dermatological diode laser 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: December 1, 2021 Received: December 9, 2021

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.

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 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

2

Indications for Use

510(k) Number (if known) K212478

Device Name Dermatological diode laser system

Indications for Use (Describe)

The Dermatological diode laser 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.

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: K212478

  • Date of Preparation 1.
    01/13/2022

  • Sponsor 2.

Beijing Stelle Laser Technology Co., Ltd.

Rm.502-1, Tower B, Building1, Yard 26, Zhongguancun Medical Device Park, Yongwang West Rd., Biomedical Industry Base, Daxing Dist., 102600 Beijing, P.R. China Contact Person: Zhao Changcheng Position: General Manager Tel: +86 13911687160 Fax: +86-10-53357993 Email: info@stellelaser.com.cn

3. Submission Correspondent

Contact Person:

Mr. Ray Wang Tel: +86-18910677558 Fax: +86-10-52214696 Email: ray.wang@believe-med.com

Beijing Believe-Med 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 4.

Trade Name: Dermatological diode laser system Common Name: Powered Laser Surgical Instrument Model(s): ADPL2/ALD1/DPL4/LD1

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 Dermatological diode laser 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.

న్. 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.

The laser light targets on melanin and treat selectively in a precise way. Melanin could absorb the energy from the laser, which would result in temperature rapid increase, to destroy germinal cell and does not damage epidermis and the surrounding normal tissue. After laser exposure, the debris of these cells is removed from the body by phagocytic cells.

The four models of different products produced by our company are consistent in Wavelength , Energy Fluence, Pulse Duration, Energy deviation, Spot Size, Frequency and so on. It's just that the shell is slightly different.

ADPL2ALD1DPL4LD1
Wavelength808nm±10nm808nm±10nm808nm±10nm808nm±10nm
Energy Fluence1-120J/cm²
(Adjustable)1-120J/cm²
(Adjustable)1-120J/cm²
(Adjustable)1-120J/cm²
(Adjustable)
Pulse Duration10-400 ms10-400 ms10-400 ms10-400 ms
Energy deviation±20%±20%±20%±20%
Spot Size12*12mm12*12mm12*12mm12*12mm
Frequency1-10Hz1-10Hz1-10Hz1-10Hz

5

Pictures of four models of shell:

Image /page/5/Picture/2 description: The image shows a medical device that is white and blue. The device has a screen on the top and a handle on the side. The device is on wheels, which makes it easy to move around. There is a red button and a keyhole on the front of the device.

ADPL2

Image /page/5/Picture/4 description: This image shows a white and gold laser hair removal machine. The machine has a screen at the top, a red button, and a gold accent. The machine is on wheels, and there is a white cord attached to the side.

ALD1

Image /page/5/Picture/6 description: The image shows a white medical device on wheels. The device has a screen on top and a handle on the side. There is a red button on the front of the device. The device is used for medical treatments.

DPL4

Image /page/5/Picture/8 description: The image shows a white and gold laser hair removal machine. The machine has a screen at the top, a handle on the side, and wheels on the bottom. The machine is designed to be used in a professional setting, such as a salon or spa.

LD1

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    1. Identification of Predicate Device
      Predicate Device 510(k) Number: K162659 Product Name: Diode Laser Hair Removal System Manufacturer: Shandong Huamei Technology Co., Ltd.

Non-Clinical Test Conclusion 7.

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:

  • AAMI ES60601-1:2005+A1:2012 Medical Electrical Equipment - Part 1: General Requirements for Safety and Essential Performance;

  • IEC 60601-2-22:2007, 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: 2007, Safety of laser products - Part 1: Equipment classification and requirements.

  • IEC 60601-1-2:2007, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests.

  • 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

  • Performance Testing for Spot Size Accuracy and Energy Output Accuracy.

  • Software Validation & Verification Test

  • Clinical Test Conclusion 8.

No clinical study is included in this submission.

    1. Substantially Equivalent (SE) Comparison
ITEMProposed Device(K212478)Predicate Device (K162659)Remark
Product
CodeGEXGEXSame
Regulation
No.21 CFR 878.481021 CFR 878.4810Same

Table 1 General Comparison

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Class22Same
Intended
UseThe Dermatological diode laser 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 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.Same
ConfigurationMain UnitMain UnitSame
HandpieceHandpieceSame
Foot ControlFoot ControlSame
Principle of
OperationDiode LaserDiode LaserSame

8

ITEMProposed Device(K212478)Predicate Device (K162659)Remark
Laser TypeDiode LaserDiode LaserSame
Laser
ClassificationClass IVClass IVSame
Laser
wavelength808 nm808 nmSame
Spot Size12×12mm14×14mmAnalysis 1
Fluence120J/cm²1-120J/ cm2Same
Pulse Duration10-400ms5-400msSimilar
Power Supply100/110V,50/60Hz or 230-260V,50/60HzAC 110V/60HzAnalysis 2
Dimension519mm×923mm×474mm450mm× 550mm×380mmAnalysis 3
Weight42Kg52KgAnalysis 4

Table 2 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 substantially equivalency.

Analysis 2

The proposed device is different in fluence from the predicate device, the difference is very slight. 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 (Energy density and Spot Size), the safety and performance of the product can be ensured. So the proposed device is determined to be substantially equivalency with predicate device.

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 substantial equivalency.

9

ItemProposed Device(K212478)Predicate Device (K162659)Remark
EMC, Electrical and Laser Safety
Electrical SafetyComply with IEC 60601-1, IEC 60601-2-22Comply with IEC 60601-1, IEC 60601-2-22Same
EMCComply with IEC 60601-1-2Comply with IEC 60601-1-2Same
Laser SafetyComply with IEC 60601-2-22, IEC 60825Comply with IEC 60601-2-22, IEC 60825Same
Patient Contact Materials and Biocompatibility
Patient Indirect
Contact
MaterialsABS plastic.
Metal aluminum.
Window QuartzSapphire in handpieceSimilar
CytotoxicityNo CytotoxicityNo CytotoxicitySame
SensitizationNo evidence of sensitizationNo evidence of sensitizationSame
IrritationNo evidence of irritationNo evidence of irritationSame

Table 3 Safety Comparison

10. Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device. Any difference in the technological characteristics does not raise any new issues or concerns of safety or effectiveness.