Looper (Model: ZX-579S) is a hand-held device for over-the counter aesthetic purposes. The Photon mode red light is indicated for the use in treating wrinkles on the blue light is indicated for the treatment of the mild to moderate inflammatory acne.

Device Description

Looper (Model: ZX-579S) is a hand-held device for over-the-counter aesthetic purposes, it's a multifunctional comprehensive beauty instrument. It's combined with the two kinds of operation functions: SONIC and PHOTON mode.

Sonic mode: The Sonic waves can provide vibrating to facial skin. The device provides 5 vibration intensities for users to choose from.

Photon mode: The red light is intended for use in treating wrinkles on the face, and the blue light is intended for the treatment of the mild to moderate inflammatory acne. It emits energy in the red spectrum for the treatment of facial wrinkles. The therapeutic probe is designed for direct contact with the face for treatment.

The Looper device consists of an applicator and charging base. An applicator is a hand-held unit used for treatment. The treatment surface is located at the applicator tip and comes in direct contact with the skin. The charging base charging for the applicator. And there is no external data connection capability (e.g., through USB, Ethernet, WiFi, Bluetooth, etc.) for the device.

There are two keys: the PHOTON key and the SONIC key. The PHOTON is to select red light and the Sonic is to select the SONIC mode and adjust the sonic. Both keys can turn on/off the device.

AI/ML Overview

The provided text describes the 510(k) summary for the "Looper (Model: ZX-579S)" device, which is an over-the-counter powered light-based device for aesthetic purposes, specifically for treating wrinkles and mild to moderate inflammatory acne.

Based on the document, this is a substantially equivalent (SE) determination based on comparison to predicate devices and adherence to relevant safety and performance standards. It is not a study that proves the device meets specific performance acceptance criteria based on clinical outcomes or AI model performance. The document emphasizes compliance with safety and performance standards (like IEC 60601 series) rather than clinical efficacy studies with predefined acceptance criteria. Therefore, most of the requested information regarding AI model performance, clinical study design, and ground truth establishment is not available in this document.

This device is a physical light-based therapy device, not an AI/ML-based diagnostic or assistive device. Thus, questions related to AI model performance, test sets, training sets, expert adjudication, MRMC studies, and AI-specific ground truth are not applicable to this 510(k) submission.

Here's a breakdown of what is provided and why other requested information is absent:

Device Performance and Acceptance Criteria (as per this document)

The "acceptance criteria" in this context are primarily related to safety, electrical performance, electromagnetic compatibility (EMC), usability, and biocompatibility, as outlined by the referenced IEC and ISO standards. The "study that proves the device meets the acceptance criteria" refers to lab bench testing against these engineering and safety standards, rather than clinical trials demonstrating efficacy with specific performance metrics.

Table of Acceptance Criteria and Reported Device Performance:

Criteria Type	Standard/Requirement	Reported Performance/Compliance Status
Electrical Safety	IEC 60601-1: 2005+A1: 2012	Compliant ("evaluated the safety and performance by lab bench testing")
Home Healthcare Env.	IEC 60601-1-11 (Edition 2.0): 2015	Compliant ("evaluated the safety and performance by lab bench testing") - specifically mentioned in comparison to predicate devices regarding "Irradiation area" and "Irradiance" as compliant with IEC 60601-1-11.
EMC	IEC 60601-1-2: 2014-02	Compliant ("evaluated the safety and performance by lab bench testing")
Light Source Safety	IEC 60601-2-57 (First Edition): 2011	Compliant ("evaluated the safety and performance by lab bench testing") - specifically mentioned in comparison to predicate devices regarding "Irradiation area" and "Irradiance" as compliant with IEC 60601-2-57.
Battery Safety	IEC 62133-2 Edition 1.0 2017-02	Compliant ("evaluated the safety and performance by lab bench testing")
Usability	IEC 60601-1-6: 2013 (Edition 3.1), IEC 62366-1: 2015	Compliant ("evaluated the safety and performance by lab bench testing") - Also mentions "Self Selection and Usability". Differences in physical characteristics (weight, dimensions, indicators) are stated as not affecting safety or effectiveness, implying underlying usability and safety aspects are met.
Software Life-cycle	IEC 62304: Edition 1.1 2015-06	Compliant ("evaluated the safety and performance by lab bench testing"). The device explicitly states "Software/Firmware/Microprocessor Control? Yes" and "User Override Control? Yes," implying software safety and control.
Biocompatibility	ISO 10993-5:2009, ISO 10993-10: 2010	"materials and manufacturing used for the subject device are identical to those of the device K171821, and the materials have been demonstrated to conform with the following biocompatibility standards." (Indirectly states compliance based on predicate device's materials.)
Irradiation Specs	(Implicitly compared to predicate devices & standards)	Red light: 630±10nm, 55mW/cm²±10%. Blue light: 415±10nm, 48mW/cm²±10%. Irradiation area: 12cm²±10%. Stated as "all compliance with IEC 60601-1-11 and IEC 60601-2-57 requirements," and not raising safety/effectiveness issues despite differences from predicates.
Physical Specs	(Implicitly compared to predicate devices)	Main Unit Weight: 230g. Dimensions: 234.5mm x 30mm x 46mm. Power Source: DC 3.7V 1000mA Li-battery. Indicators: low battery, PHOTON/SONIC mode info, intensity level, charging. Stated as "all compliance with IEC 60601-1 requirement for the product and not affect the safety or effectiveness."
Operating Env.	(Implicitly compared to predicate devices)	Temp: 5~~35°C, Humidity: 10~~80%RH, Pressure: 700hPa~1060hPa. Stated as "SE" (substantially equivalent) to predicates, implying meeting acceptable ranges for performance in typical use environments.
Transport/Storage Env.	(Implicitly compared to predicate devices)	Temp: -10~~40°C, Humidity: 5~~95%RH, Pressure: 600hPa~1060hPa. Stated as "SE," implying stability and safety during non-operational phases.

Reasons for Missing Information & Inapplicability:

This document is a 510(k) Pre-market Notification for a physical medical device (light therapy), not an Artificial Intelligence/Machine Learning (AI/ML) enabled device. Therefore, the following requested information is not applicable or not provided in this type of submission:

Sample sized used for the test set and the data provenance: Not an AI/ML device. "Test set" refers to engineering verification and validation against standards, not a clinical data set for AI model evaluation. The data provenance is "lab bench testing."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not an AI/ML device. Ground truth for an AI/ML algorithm (e.g., image annotation) is not relevant here. Ground truth here means compliance with established engineering and medical device safety standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for a physical device's engineering and safety verification.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not an AI/ML device. MRMC studies are for evaluating performance of AI-assisted diagnostic tools.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not an AI/ML device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device revolves around objective measurements of light output, electrical safety, ergonomic performance, and adherence to established biocompatibility and usability standards. It's not about clinical outcomes or diagnostic accuracy in the way an AI model would be.
The sample size for the training set: Not an AI/ML device.
How the ground truth for the training set was established: Not an AI/ML device.

In summary, the 510(k) for the Looper device demonstrates substantial equivalence to predicate devices and compliance with relevant safety and performance standards for light-based medical devices through lab bench testing. It does not involve AI/ML components or associated clinical validation studies that would require the specific data points requested in your prompt.

Summary

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April 16, 2021

Heat In A Click LLC % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou, Guangdong 510006 China

Re: K202055

Trade/Device Name: Looper (Model: ZX-579S) Regulation Number: 21 CFR 878.4810 Regulation Name: over-the-counter powered light based laser for acne Regulatory Class: Class II Product Code: OLP, OHS Dated: March 9, 2021 Received: March 12, 2021

Dear Cassie Lee:

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 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202055

Device Name Looper (Model: ZX-579S)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary of K202055

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

1. Submitter's Information

Company Name: Heat In A Click LLC Establishment Registration Number: 3008929787 Address: 1975 Tigertail Blvd Dania Florida 33034 USA Phone: 1(954)518-9777 Fax No.: 1(954)320-7984 Contact Person (including title): Guy Levi (CEO) E-mail: hagar@palmmassager.com

Factory:

510(k) Owner's Name: Hong Qiang Xing (Shenzhen) Electronics Limited Establishment Registration Number: Applying Address: 4F., Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen, Guangdong Province, PRC Phone: +86-755-26423615 Fax No.: +86-755-29915485 Contact Person (including title): Mr. Xu Jianhua (General Manager) E-mail: info@sunmas.com

Application Correspondent:

Contact Person: Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China Tel: +86 20 8266 2446 Email: regulatory@glomed-info.com

2. Subject Device Information

Common Name: Electrosurgical device for over-the-counter aesthetic use Classification Name: Over-The-Counter Powered Light Based Laser For Acne (OLP), Light Based Over The Counter Wrinkle Reduction (OHS) Trade Name: Looper (Model: ZX-579S)

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Review Panel: Neurology; General & Plastic Surgery Product Code: OHS, OLP Regulation Number: 878.4810, 878.4420 Regulation Class: II

3. Predicate Device Information

Sponsor	Heat In A Click	Li-Tek ElectronicsTechnologies	AEGIS Regulatory, Inc.
DeviceName andModel	2 Face / Face Evolution(Model:2Face / Face Evolution)	LED Phototherapy Device	Elevare Plus
510(k)Number	K171821	K162098	K172909
ProductCode	NFO, OHS, OLP	OLP, OHS	OHS
RegulationNumber	882.5890	878.4810	878.4810
RegulationClass	II	II	II

4. Device Description

Sonic mode: The Sonic waves can provide vibrating to facial skin. The device provides 5 vibration intensities for users to choose from.

There are two keys: the PHOTON key and the SONIC key. The PHOTON is to select red light and the Sonic is to select the SONIC mode and adjust the sonic. Both keys can turn on/off the device.

5. Intended Use / Indications for Use

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6. Test Summary

The Looper (Model: ZX-579S) has been evaluated the safety and performance by lab bench testing as following:

. IEC 60601-1: 2005+A1: 2012, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
� IEC 60601-1-11 (Edition 2.0): 2015, Medical electrical equipment -- part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
◆ IEC 60601-1-2: 014-02, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - collateral standard: Electromagnetic Compatibility.
◆ IEC 60601-2-57 (First Edition): 2011 for use in conjunction with IEC 60601-1:2005, Medical Electrical Equipment - Part 2-57 : Particular requirements for the basic safety and essential performance of nonlaser light source equipment intended for therapeutic, monitoring and cosmetic/aesthetic use.
◆ IEC 62133-2 Edition 1.0 2017-02, Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems.
. IEC 60601-1-6: 2013 (Edition 3.1), Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
. IEC 62366-1: 2015 (First Edition), Medical devices - Application of usability engineering to medical devices.
◆ IEC 62304: Edition 1.1 2015-06, Medical device software, Software life- cycle processes.
◆ Self Selection and Usability

7. Comparison to predicate device and conclusion

Although there has some slight differences between with subject device and predicate device, the subject device Looper (model: ZX-579S) is Substantial Equivalence to all predicate devices. Because compare with predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between subject device and predicate device do not raise and new questions of safety or effectiveness.

Elements ofComparison	Subject Device	PredicateDevice 1(PrimaryDevice)	PredicateDevice 2	PredicateDevice 3	Remark
Elements ofComparison	Subject Device	PredicateDevice 1(PrimaryDevice)	PredicateDevice 2	PredicateDevice 3	Remark
Company	Heat In A ClickLLC	Heat In A Click	Li-TekElectronicsTechnologies	AEGISRequlatory,Inc.	--
Trade Name	Looper	2 Face / FaceEvolution	LEDPhototherapyDevice	Elevare Plus	--
ClassificationName	Light Basedover theCounterWrinkleReduction,Over-the-counterpowered lightbased for acne	Transcutaneous Electrical,AestheticPurposes,Light BasedOver TheCounterWrinkleReduction,Over-The-CounterPowered LightBased LaserFor Acne	Light Basedover theCounterWrinkleReduction,Over-the-counterpowered lightbased for acne	Light BasedOver-The-CounterWrinkleReductionDevice	SE
510(k)Number	K202055	K171821	K162098	K172909	--
Product Code	OHS, OLP	NFO, OHS,OLP	OLP, OHS	OHS	SE
Intended Use /Indications forUse	Looper(Model: ZX-579S) is ahand-helddevice forover-thecounteraestheticpurposes. ThePhoton modered light isindicated forthe use intreatingwrinkles onthe face, andthe blue lightis indicatedfor thetreatment ofthe mild tomoderateinflammatoryacne.	The subjectdevice is ahand-helddevice forover-thecounteraestheticpurposes andit's intendeduse for:(1) The EMSmode isindicated forfacialstimulation;(2) ThePhoton mode:The red light isintended forthe treatmentof periorbitalwrinkles andthe blue lightis intended forthe treatmentof the mild tomoderate	The red light isintended forthe treatmentof periorbitalwrinkles, andthe blue lightis intended forthe treatmentof the mild tomoderateinflammatoryacne.	The ElevarePlus is anOver-the-Counter (OTC)deviceintended forthe use intreatingwrinkles onthe face.	SE
Elements ofComparison	Subject Device	PredicateDevice 1(PrimaryDevice)	PredicateDevice 2	PredicateDevice 3	Remark
		inflammatoryacne.
AnatomicalSites	Entire Face	Entire Face	Entire Face	Entire Face	SE
Design	Hand-helddevice	Hand-helddevice	Hand-helddevice	Hand-helddevice	SE
TargetPopulation	Individualswith wrinkleson face,Individualswith mild tomoderateinflammatoryacne	Individualswith periorbitalwrinkles,Individualswith mild tomoderateinflammatoryacne	Individualswith periorbitalwrinkles,Individualswith mild tomoderateinflammatoryacne	Individualswith wrinkleson face	SE
Environmentof Use	Home	Home	Home	Home	SE
Method of LinecurrentIsolation	Type BF	Type BF	Type BF	Not publiclyavailable	SE
Main UnitWeight	230g	200g	150g	Not publiclyavailable	SENote 1
Dimensions ofdevice	234.5mm x30mm x 46mm	158mm x56mm x 51.5mm	187mm x65mm x 51mm	Not publiclyavailable	SENote 1
HousingMaterials ofmain unit	ABS Plastic &Stainless Steel	ABS Plastic &Stainless Steel	ABS Plastic	Not publiclyavailable	SE
Power Source	DC 3.7V1000mA Libattery	DC 3.7V2200mAh	DC 3.7V1050mA Libattery	2 Li-Ionrechargeablebatteries	SE
Software/Firmware/MicroprocessorControl?	Yes	Yes	Yes	Yes	SE
AutomaticShut Off	Yes	Yes	Yes	Yes	SE
User OverrideControl?	Yes	Yes	Yes	Yes	SE
Indicators	Indicates forlow battery,PHOTONmodeinformation,SONIC modeinformation,intensity level,ChargingIndicator	EMS ModeintensityIndicatorlights, PhotonMode workingindicatorlights, PhotonMode Indicatorlights,ChargingIndicator	Not publiclyavailable	Not publiclyavailable	SENote 1
Time Range	3 minutes per	EMS Mode (5	3 minutes per	3 minutes	SE
Elements ofComparison	Subject Device	PredicateDevice 1(PrimaryDevice)	PredicateDevice 2	PredicateDevice 3	Remark
(minutes)	target area; 2treatments perweek for 6weeks	minutes)Photon Mode(5~7 minutes)	target area; 2treatments perweek for 6weeks	daily, 5 daysper week for 8weeks
Wavelengths	Red:630±10nmBlue:415±10nm	Red Light(630nm±3nmWavelength)Blue Light(415nm±3nmWavelength)	Red: 630±3nmBlue:415±3nm	RED: 610,630, 660,850nm(±5mm)	SE
The distancebetween theLEDs totreatmentsurface	Close to thefacial skin	2-3 cm	2-3 cm	Close to thefacial skin	SE
Irradiationarea	12cm2±10%	26cm2±5%	30cm2±5%	Over 17cm²	SENote 2
Irradiances	Red light:55mW/cm2±10%Blue light:48mW/cm2±10%	Red light:73.26mW/cm2±10%Blue light:64.10mW/cm2±10%	Red light:80mW/cm2±10%Blue light:65mW/cm2±10%	65mW/cm2(±5mW)	SENote 2
Irradiancesource	LED	LED	LED	LED	SE
Visible lightLEDs	Yes	Yes	Yes	Yes	SE
EMC	IEC 60601-1-2	IEC 60601-1-2	IEC 60601-1-2	IEC 60601-1-2	SE
Safety	IEC 60601-1,IEC 60601-1-11 and IEC60601-2-57	IEC 60601-1,IEC 60601-2-10 and IEC60601-2-57	IEC 60601-1and IEC60601-2-57	IEC 60601-1,IEC 60601-1-11	SE
WorkingEnvironment	Temperature:5~~35°CHumidity:10~~80%RHAtmosphericpressure:700hPa~1060hPa	Not publiclyavailable	Temperature:5~~40°CHumidity:10~~80%RHAtmosphericpressure:700hPa~1060hPa	Not publiclyavailable	SE
Transportationand StorageEnvironment	Temperature: -10~~40°CHumidity:5~~95%RHAtmosphericpressure:600hPa~1060hPa	Not publiclyavailable	Temperature: -10~~40°CHumidity:5~~95%RHAtmosphericpressure:600hPa~1060hPa	Not publiclyavailable	SE

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Comparison in Detail(s): Note 1:

Although the "Main Unit Weight", "Dimensions of device", "Power source" and "Indicator" of subject device is different from the predicate devices, they are all compliance with IEC 60601-1 requirement for the product and not affect the safety or effectiveness. So the differences of function specification will not raise any safety or effectiveness issue.

Note 2:

Although the "Irradiation area" and "Irradiance" is a little different from the predicate devices, they are all compliance with IEC 60601-1-11 and IEC 60601-2-57 requirements. So the differences will not raise any safety or effectiveness issue.

Note 3:

The Nature of body contact is skin contact. And the contact duration is less than 24 hours. The materials and manufacturing used for the subject device are identical to those of the device K171821, and the materials have been demonstrated to conform with the following biocompatibility standards:

· 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 delayedtype hypersensitivity

Final Conclusion:

Although there has some slight differences between with subject device and predicate device, the subject device Looper (Model: ZX-579S) is Substantial Equivalence to the predicate devices K171821, K162098 and K172909. Because compare with predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. And the subject meets the same standards as the predicate device, so the differences between subject device and predicate device do not raise and new questions of safety or effectiveness.

Date of the summary prepared: 2021-04-16

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.