K Number

Device Name

Q-Switched Nd:Yag laser

Manufacturer

Hebei Zhemai Technology Co., Ltd

Date Cleared

2023-11-30

(86 days)

Product Code

GEX

Regulation Number

878.4810

Intended Use

The Q-Switched Nd: Yag laser is indicated for the treatment of: benign cutaneous lessons, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, nevus, and the removal of black or blue tattoos.

Device Description

The Q-switched laser therapy device is laser system which delivers laser at a wavelength 1064nm or 532nm and the pulse mode is single pulse. In laser handpiece, there is one optical cavity containing the Nd: YAG crystal. The laser beam is directed to the treatment zone. When the laser beam contacts human tissue, the energy in the beam is absorbed, resulting in a very rapidly, highly localized temperature increase to the target tissue. The instantaneous temperature increase (thermal effect) causes the cells change of target tissue to achieve laser treatment effect.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K161926

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a laser therapy device with a standard mechanism of action and does not mention any AI/ML components or capabilities.

Therapeutic

Yes

Explanation: The device is indicated for the treatment of various benign cutaneous lesions, including warts, scars, striae, psoriasis, lentigines, nevus, and the removal of tattoos, indicating a therapeutic purpose.

Diagnostic

This device is a therapeutic device intended for treating various benign cutaneous lesions and for tattoo removal, not for diagnosing conditions.

SaMD (Software as a Medical Device)

The device description clearly states it is a "laser system" with a "laser handpiece" containing an "optical cavity" and an "Nd: YAG crystal," indicating it is a hardware device that delivers laser energy. The performance studies also include non-clinical tests related to electrical and laser safety standards, further confirming it is a hardware device.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Device Function: The description clearly states that this device is a laser system that delivers energy directly to human tissue for treatment purposes (treating lesions, removing tattoos). It does not analyze samples taken from the body.
Intended Use: The intended use is for the treatment of various skin conditions and tattoo removal, not for diagnostic testing of samples.

Therefore, based on the provided information, this device is a therapeutic laser device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Q-Switched Nd: Yag laser is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, nevus, and the removal of black or blue tattoos.

Product codes

GEX

Device Description

The Q-switched laser therapy device is laser system which delivers laser at a wavelength 1064nm or 532nm and the pulse mode is single pulse.

Model: FQ-L08

In laser handpiece, there is one optical cavity containing the Nd: YAG crystal. The laser beam is directed to the treatment zone. When the laser beam contacts human tissue, the energy in the beam is absorbed, resulting in a very rapidly, highly localized temperature increase to the target tissue. The instantaneous temperature increase (thermal effect) causes the cells change of target tissue to achieve laser treatment effect.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

cutaneous lesions, pigmented lesions (implied skin)

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:

ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EC 60601-1-2 Edition 4.1 2020-09, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
IEC 60601-2-22 2019 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
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.
Software Validation & Verification Test

The proposed device has different Pulse Width from the predicate device. Pulse Width of proposed device is within the predicate device. And the proposed device has passed the IEC 60601-1 test, IEC 60601-1-2 test, IEC 60601-2-22 test, IEC 60825-1 test, the safety and performance of the product can be ensured.

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

Not Found

Predicate Device(s)

K161926

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

Image /page/0/Picture/0 description: The image contains 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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

November 30, 2023

Hebei Zhemai Technology Co., Ltd Rav Wav Official Correspondent 1st FL, N of No.1 Warehouse, W of Shuichang Rd, N of Beiyi Rd, Yanjiao Development Zone, Sanhe Langfang, Hebei 065201 China

Re: K232716

Trade/Device Name: O-Switched Nd:Yag laser 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: September 4, 2023 Received: September 5, 2023

Dear Ray Way:

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/ofdocs/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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Tanisha L. Hithe -Tanisha L.s 2023.11.30 Hithe -S 16:03:30 -05'00'

Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical & Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K232716

Device Name Q-Switched Nd:Yag laser

Indications for Use (Describe)

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: _________________________________________________________________________________________________________________________________________________

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.

1. Date of Preparation:2023/11/30
1. Sponsor Identification

Hebei Zhemai Technology Co.,Ltd

1st Floor, North of No.1 Warehouse, West of Shuichang Road, North of Beiyi Road, Yanjiao Development Zone, Sanhe, Langfang, Hebei, China, 065201 Contact Person: Yuting Qu Position: Sales Manager Tel: +86-18678802036 Email: feijiakeji@zoho.com.cn

1. Designated Submission Correspondent
  Mr. Ray Wang Tel: +86-18910677558 Fax: +86-10-56335780 Email: information@believe-med.com

Identification of Proposed Device 4.
Trade Name: Q-Switched Nd:Yag laser

Common Name: Powered Laser Surgical Instrument

Regulatory Information Classification Name: Powered Laser Surgical Instrument Classification: II Product Code: GEX Regulation Number: 878.4810 Review Panel: General & Plastic Surgery

న. Indication For Use Statement:
The Q-Switched Nd:Yag laser is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, nevus, and birthmark; and the removal of black or blue tattoos.
1. Device Description
  The Q-switched laser therapy device is laser system which delivers laser at a wavelength 1064nm or 532nm and the pulse mode is single pulse.

Model: FQ-L08

No.	Component name	Function
1	Main unit	Main Interface
2	Smart Optics 7 Arms	Articulated arm for holding of Treatment Probe
3	Treatment head	Laser Deliver
4	Foot switch	Control pulse light output
5	Patient goggles	Eye protection
6	Doctor goggles	Eye protection
7	Treatment head bracket	Support and fix the treatment head
8	Key	Start device
9	Power cord	Supply power
10	Damping	It has a shock absorption effect

	Table 1 Main Components introduction

1. Identification of Predicate Device(s)
  510(k) Number: K161926 Product Name: ND YAG Q-switch Laser Therapy Machine Manufacturer: Beijing ADSS Development Co., Ltd
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:
A ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EC 60601-1-2 Edition 4.1 2020-09, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
IEC 60601-2-22 2019 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
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.
Software Validation & Verification Test

| ITEM | Proposed Device | Predicate Device 1
K161926 | Remark |
|----------------|-----------------|-------------------------------|--------|
| Product Code | GEX | GEX | SE |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | SE |
| Class | 2 | 2 | SE |

Table 2 General Comparison

Intended Use		SE
The Q-switched laser therapy device
is indicated for the treatment of:
benign cutaneous lesions, such as
Warts, Scars, Striae and Psoriasis;
benign pigmented lesions, such as
Lentigines, nevus, and birthmark; and
the removal of black or blue tattoos.	The ND YAG Q-switch Laser
Therapy Machine is indicated for the
treatment of:
benign cutaneous lesions, such as
Warts, Scars, Striae and Psoriasis;
benign pigmented lesions, such as
Lentigines, nevus, and birthmark;
and the removal of black or blue
tattoos.

Table 3 Performance Comparison

| ITEM | Proposed Device | Predicate Device 1
K161926 | Remark |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|------------|
| Laser Medium | Nd:YAG | Nd:YAG | SE |
| Wavelength | 1064nm 532nm | 1064 nm
532 nm | SE |
| Output energy | 10-1000mJ for 1064nm
50-500mJ for 532nm | 100-1000mJ for 1064nm
50-500mJ for 532nm | SE |
| Max. Energy Density | 31.8J/cm² for 1064nm
15.9 J/cm² for 532nm | 31.8J/cm² for 1064nm
15.9 J/cm² for 532nm | SE |
| Spot Size | 2-10mm | 2-10mm | SE |
| Pulse Width | 6ns | 5ns-8ns | Analysis 1 |
| Repetition Rate | 1-10Hz | 1-10 Hz | SE |
| Disinfection | Arms without focusing lenses and
probes can be disinfected with a 75%
medical grade alcohol wipe. | Disinfect the handpiece before and
after every treatment by 75%
medicinal alcohol | SE |
| Laser Class | Class 4 | Class 4 | SE |
| Cooling method for
treated skin area | Closed water circulation | N.A. | SE |

| Aiming Beam |