Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. Mixed light: Treatment of mild to moderate inflammatory acne.

Device Description

LED light therapy mask is a home use wearable LED phototherapy device which can help solve various skin problems. LED light therapy mask is consisting of mask, controller, adapter, USB cable and straps.

There are 4 kinds of light which include Red light (wavelength 620mm), Blue light (wavelength 460nm), Infrared light (wavelength 850mm), Mixed light (wavelength 620mm and 850nm and 460nm).

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (LED light therapy mask) seeking clearance from the U.S. FDA. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with detailed performance metrics.

Therefore, the document does not contain the specific information requested in your prompt regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or detailed ground truth establishment for a specific study conducted for this device.

Instead, the document primarily compares the subject device to several predicate devices across various characteristics and lists non-clinical tests conducted to ensure safety and compliance with relevant standards. It explicitly states, "Clinical data: Not applicable."

Here's a breakdown of what can be extracted or inferred based on your request, and what is not available in the provided text:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the document. The 510(k) summary focuses on demonstrating substantial equivalence through comparison to predicate devices and adherence to recognized standards, not on presenting specific performance criteria and results of a dedicated study for the current device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not available. The document explicitly states "Clinical data: Not applicable," meaning no clinical test set was used for this 510(k) submission to demonstrate the device's efficacy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable/not provided. Since no clinical test set with human assessments or ground truth establishment relevant to efficacy is mentioned, there are no experts establishing ground truth in this context. The document focuses on regulatory compliance and technical equivalence.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable/not provided. Without a clinical test set requiring adjudication, this detail is irrelevant to this submission.

5. 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:

This information is not applicable/not provided. The device is an LED light therapy mask, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable/not provided. This is a physical device (LED light therapy mask), not an algorithm or software-only device. Therefore, a standalone algorithm performance study is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

This information is not applicable/not provided. Since no clinical efficacy study or test set for the device's indications is presented, there is no discussion of the type of ground truth used to validate its performance for those indications. The "ground truth" in this context is the performance and safety established for the predicate devices and the compliance to international safety standards.

8. The sample size for the training set:

This information is not applicable/not provided. As "Clinical data: Not applicable" is stated, there is no mention of a training set for an algorithm.

9. How the ground truth for the training set was established:

This information is not applicable/not provided. No training set for an algorithm is mentioned.

Summary of available information related to the device's 'proof' and acceptance:

The 'proof' for the LED light therapy mask meeting the criteria for market clearance (not specific acceptance criteria against a clinical study) relies on demonstrating substantial equivalence (SE) to legally marketed predicate devices and compliance with recognized non-clinical safety standards.

Non-clinical tests performed (supporting safe operation, not efficacy for treatment claims):

Electrical safety: ANSI AAMI ES 60601-1
Electromagnetic compatibility: IEC 60601-1-2
Home healthcare environment requirements: IEC 60601-1-11
Safety of non-laser light source equipment: IEC 60601-2-57
Biocompatibility:
- ISO 10993-5 (In Vitro Cytotoxicity)
- ISO 10993-10 (Irritation and Skin Sensitization)
Software verification and validation testing: Conducted as per FDA's guidance for software in medical devices.

Conclusion stated in the document:

"The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate that LED light therapy mask should perform as intended in the specified use conditions, and all the data demonstrate that the subject devices perform comparably to the predicate device that is currently marketed for the same intended use. In other words, the subject device (LED light therapy mask) is Substantial Equivalent to the predicate devices K200983, K221151, K162489 and K212155."

Summary

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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 in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.

February 23, 2023

Guangdong Newdermo Biotech Co.,Ltd Annie Cai Certificate Engineer Building C28. Huachuang Industrial Park, Jinshan Avenue Shiji Town, Panyu Guangzhou. 511450 China

Re: K223544

Trade/Device Name: LED light therapy mask (FM-01, FM-02, FM-03) 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: OHS, OLP, ILY Dated: November 24, 2022 Received: November 25, 2022

Dear Annie Cai:

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 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.

Jianting Wang -S

Jianting Wang Acting 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) K223544

Device Name LED light therapy mask (FM-01, FM-02, FM-03)

Indications for Use (Describe)

Red light: Treatment of full-face wrinkles.

Blue light: Treatment of mild to moderate inflammatory acne.

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

For activities identified in 37.44, Subpart D
For Streamlined permitting under 37.44, Subpart C

| | 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 K223544

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510 (K) Summary

Prepared in accordance with the content and format regulatory requirements of 21 CFR Part 807.92

1. Submitter:

510(k) owner's name:	Guangdong Newdermo Biotech Co.,Ltd
Address:	Building C28. Huachuang Industrial ParkJinshan Avenue, Shiji Town,Panyu, Guangzhou,511450 P.R. China
Tel:	+86(020) 31105688
Contact person:	Annie Cai
Email:	caidejiao@qq.com
Preparing date:	February 22, 2023
2. Device name and classification:
Device Name:	LED light therapy mask
Model:	FM-01, FM-02, FM-03
Classification Name/Product code:	21 CFR 878.4810 OHS21 CFR 878.4810 OLP21 CFR 890.5500 ILY
Regulatory Class:	Class II

3.Premarket Notification Class III Certification and Summary

Not applicable, the subject device is Class II.

4. Predicate Device(s):

1) Predicate device1

Sponsor:	NINGBO HESI ELECTRIC CO., LTD
Device name:	LED FACIAL LIGHT THERAPY MASK, FLEXIBLE LED LIGHTTHERAPY
510(k) Number:	K200983
Product Code:	OHS, OLP, ILY
2) Predicate device2
Sponsor:	Hunan Guangye Biotechnology Co., Ltd.
Device name:	Beauty LED Mask

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Traditional 510(k) Submission of LED light therapy mask

510(k) Number:	K221151
Product Code:	OHS, OLP
3) Predicate device3
Sponsor:	Zhongshan Bisen Plastic Electronic Products Co.,Ltd.
Device name:	RED Light Device
510(k) Number:	K162489
Product Code:	OHS
4) Predicate device4
Sponsor:	Theragun, Inc.
Device name:	TheraFace LED
510(k) Number:	K212155
Product Code:	OHS, OLP
5) Reference device
Sponsor:	Xuzhou Kernel Medical Equipment Co., Ltd.
Device name:	LED Light Therapy Device, KN-7000L
510(k) Number:	K222751
Product Code:	GEX

5. Reason for Submission

New device, there were no prior submissions for the device.

6. Pre-Submission, IDE

Not applicable, there is no prior submission.

7. Device Description:

There are 4 kinds of light which include Red light (wavelength 620mm), Blue light (wavelength 460nm), Infrared light (wavelength 850mm), Mixed light (wavelength 620mm and 850nm and 460nm).

8. Intended Use:

Red light: Treatment of full-face wrinkles.

Blue light: Treatment of mild to moderate inflammatory acne.

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Infrared light: Provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.

Mixed light: Treatment of mild to moderate inflammatory acne.

Item	Subject Device	Predicatedevice1(K200983)	PredicateDevice2(K221151)	ComparisonResult
Trade name	LED light therapymask	LED FACIALLIGHTTHERAPYMASK,FLEXIBLE LEDLIGHTTHERAPY	Beauty LED Mask	/
510 (k) number	K223544	K200983	K221151	/
Manufacturer	GuangdongNewdermo BiotechCo.,Ltd	NINGBO HESIELECTRIC CO.,LTD	Hunan GuangyeBiotechnology Co.,Ltd.	/
Regulationnumber	21 CFR 878.481021 CFR 890.5500	21 CFR 878.4810,21 CFR 890.5500	21 CFR 878.4810	Same
RegulationName	Light Based OverThe CounterWrinkleReduction(OHS),Over-The-CounterPowered LightBased Laser ForAcne(OLP),Infrared,TherapeuticHeating(ILY)	Light Based OverThe CounterWrinkleReduction(OHS),Over-The-CounterPowered LightBased Laser ForAcne(OLP),Lamp, Infrared,TherapeuticHeating(ILY)	Light Based OverThe CounterWrinkleReduction(OHS),Over-The-CounterPowered LightBased Laser ForAcne(OLP)	Same
Product code	OHS, OLP, ILY	OHS, OLP, ILY	OHS, OLP	Same
Classification	II	II	II	Same
Indications foruse/ Intendeduse	Red light:Treatment offull-face wrinkles.Blue light:Treatment of mildto moderateinflammatory acne.	The LED FACIALLIGHTTHERAPYMASK (Model:HK207) isintended to:The device	The device isintended to useLED light for thetreatment ofwrinkles and mildto moderate acne.	SimilarNote2

9. Predicate Device Comparison

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Infrared light:Provide topicalheating for thepurpose ofelevating tissuetemperature;arthritis and musclespasm; relievingstiffness; promotingthe relaxation ofmuscle tissue; andto temporarilyincrease local bloodcirculation.Mixed light:Treatment of mildto moderateinflammatory acne.	emitting energy inthe blue isintended to reducethe mild tomoderateinflammatory acnevulgaris.- The deviceemitting energy inthe red andinfrared spectrumis intended for thetreatment offull-face wrinkles.The FLEXIBLELED LIGHTTHERAPY(Model: HK209) isintended to:- The deviceemitting energy inthe blue isintended to reducethe mild tomoderateinflammatory acnevulgaris.- The deviceemitting energy inthe red andinfrared spectrumis intended for thetreatment offull-facewrinkles.- The device isintended to deliverheat in the IRspectrum toprovide topicalheating for thepurpose ofelevating tissue

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		the temporaryrelief of minormuscle and jointpain, arthritis andmuscle spasm;relieving stiffness;promoting therelaxation ofmuscle tissue; andto temporarilyincrease localblood circulation.
Location for use	Face and body	Entire Face andbody	Face	Same
OTC orprescription	OTC	OTC	OTC	Same
Power supply	Input:100-240 V~, 50/60Hz, 0,25 AOutput: DC 5 V,500 mA	Input: 100 –240Vac,2.0 A, 50/60Hz	Input: 100 -240 V~ 50 /60 HzOutput: 5V 1A	SimilarNote4
Light source	LED	LED	LED	same
Wavelength	Red: 620nmBlue: 460nmInfrared: 850nmMixed: 620nm and850nm and 460nm	465nm,640nm,880nm	Red (637nm±5nm)andIR (854nm±5nm);Blue (465±5nm)	Comparewithpredicatedevice 4SimilarNote 5
LED Intensity	Red light: 2.0~~3.0mW/cm²Blue light:2.0~~4.0mW/cm²Infrared light:2.0~~4.0 mW/cm²Mixed light:9.0~~12.0 mW/cm²	6.5 mW/cm²	Red+IR:25.5mW/cm²Blue: 1.36mW/cm²	SimilarNote6
Treatment time	Manual Mode:15minutes eachtime,Automatic Mode:10minutes eachtime.3-4 treatment aweek, reduce to 1-2	3 times a week for30min. 4 weeks	10min each time	Comparewithpredicatedevice 3SimilarNote7
	treatment a weekonce the resultsshown.
Dimensions(mm)	FM-01:207X277X43mm,FM-02:198X383X33.5mm,FM-03:237.5X108X8.1mm	Not public	LED Mask:Approximately 183 mm x 238 mm x 98 mmController: 100mm x 50 mm x 21.5 mm	/
Electrical safety	IEC 60601-1;IEC 60601-1-2	IEC 60601-1;IEC 60601-1-2	IEC 60601-1;IEC 60601-1-2	Same
Biocompatibilityfeature	All body-contactingmaterials arecomplied withISO10993-5 andISO 10993-10	Allbody-contactingmaterials arecomplied withISO10993-5 andISO 10993-10	Allbody-contactingmaterials arecomplied withISO10993-5 andISO 10993-10	Same

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Item	Subject Device	Predicatedevice3(K162489)	PredicateDevice4(K212155)	ComparisonResult
Trade name	LED light therapymask	RED Light Device	TheraFace LED	/
510 (k) number	K223544	K162489	K212155	/
Manufacturer	GuangdongNewdermo BiotechCo.,Ltd	Zhongshan BisenPlastic ElectronicProducts Co.,Ltd.	Theragun, Inc.	/
Regulationnumber	21 CFR 878.4810,21 CFR 890.5500	21 CFR 878.4810	21 CFR 878.4810	SimilarNote1
RegulationName	Light Based OverThe CounterWrinkleReduction(OHS),Over-The-CounterPowered LightBased Laser ForAcne(OLP),Infrared,TherapeuticHeating(ILY)	Light Based OverThe CounterWrinkleReduction(OHS),	Light Based OverThe CounterWrinkleReduction(OHS),	SimilarNote1
Product code	OHS, OLP, ILY	OHS	OHS, OLP	SimilarNote1
Classification	II	II	II	Same
Indications foruse/ Intendeduse	Red light:	The RED LightDevice is an OTCdevice indicated toemit energy in thered and IR regionof thespectrum for use indermatology forthe treatment ofperiorbitalwrinkles.	1) The red light isintended to treatperiorbitalwrinkles.2) The blue light isintended to treatmild to moderateinflammatory acne.3) The Red + IRis intended to treatperiorbitalwrinkles.	SimilarNote2
Red light:Treatment offull-face wrinklesBlue light:Treatment of mildto moderateinflammatory acne.Infrared light:Provide topicalheating for thepurpose ofelevating tissuetemperature;arthritis and musclespasm; relievingstiffness; promotingthe relaxation ofmuscle tissue; andto temporarilyincrease local bloodcirculation.Mixed light:Treatment of mildto moderateinflammatory acne.
Location for use	Face and body	/	Face	SimilarNote3
OTC orprescription	OTC	OTC	OTC	Same
Power supply	Input:100-240 V~, 50/60Hz, 0,25 AOutput: DC 5 V,500 mA	Adaptor:100~240VAC 50/60HzLithium battery:2x3.7V	Lithiumbattery :2x3.7V	SimilarNote4
Light source	LED	LED	LED	Same
Wavelength	Red: 620nmBlue: 460nmInfrared: 850nmMixed: 620nm and850nm and 460nm	Red: 633 ±5nmInfrared: 830 ±5nm	Red light:633nm±10nmBlue light:415nm±10nmRed+IR:633±10nm /830nm±10nm	Comparewithpredicatedevice 4SimilarNote 5
LED Intensity	Red light: 2.0~3.0	125 mW/cm²	Red light 73±5	Comparewith
	Blue light:2.0~~4.0mW/cm²Infrared light:2.0~~4.0 mW/cm²Mixed light:9.0~12.0 mW/cm²	nm); 55 mW/cm²(830nm)	Blue light 64±5mW/cm²Red+IR:73±5/55±5mW/cm²	predicatedevice 3SimilarNote6
Treatment time	Manual Mode:15minutes eachtime,Automatic Mode:10minutes eachtime.3-4 treatment aweek, reduce to 1-2treatment a weekonce the resultsshown.	For the first month(4 weeks),treatmentshould beperformed 3 timesa week for15-20 minutes eachtime.(5-7 minutesoneach treatmentzone).	Red light: 5 - 7minutes pertreatment zoneBlue: 5-7 minutesper treatment zoneRed+IR: 5-7minutes pertreatment zone	Comparewithpredicatedevice 3SimilarNote7
Dimensions(mm)	FM-01:207X277X43mm,FM-02:198X383X33.5mm,FM-03:237.5X108X8.1mm	/	/	/
Electrical safety	IEC 60601-1;IEC 60601-1-2	IEC 60601-1;IEC 60601-1-2	IEC 60601-1;IEC 60601-1-2	Same
Biocompatibilityfeature	All body-contactingmaterials arecomplied withISO10993-5 andISO 10993-10	Allbody-contactingmaterials arecomplied withISO10993-5 andISO 10993-10	Allbody-contactingmaterials arecomplied withISO10993-5 andISO 10993-10	Same

Guangdong Newdermo Biotech Co.,Ltd

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Comparison in Detail(s):

Note1

The Regulation number, Regulation Name, Product code of predicate1 are not identical to the subject device, all these device are process similar intended use and use very similar light wavelengths to get the intended purpose. This slight deference will not raise safety and effective issue.

Note2

The Indications for use/ Intended use of Red light, Blue light , Infrared light of the subject device is the same as that of primary device K200983. The Indications for use/ Intended use of mixed light of the subject device is the same as that of secondary device K221151.

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Note3

The treatment location of the subject device is the same as the predicate device K200983 but identical the other predicate device. The difference in applicable location will not raise safety and effective issue.

Note4

The power supply of devices are very similar but not identical, the IEC60601-1test demonstrated the safety of the power adapter. The slight difference will not raise safety and effective issue. Note5

The light wavelength is very similar but not identical. The subject device emits blue light, red light and IR light. In the mixed light mode, the subject device emits blue light, IR light simultaneously, while the reference device K222751 can emit red, blue, IR light simultaneously and it has been demonstrated that emit three lights simultaneously is safe and effect. Besides, the subject device has passed IEC60601-2-57 test, the slight difference will not raise safety and effective issue.

Note6

The LED Intensity of these devices are different, and the LED intensity of the subject device is low and subject device has passed IEC60601-2-57 test, the slight difference will not raise safety and effective issue.

Note7

The treatment time of these devices are very similar but not identical, treatment is one of the factors to get the intended purpose. What's more, the subject device has IEC60601-1, IEC60601-2-57 test, the slight difference will not raise safety and effective issue.

All the differences don't affect the safety and effectiveness which is concluded after all the required testing, so no safety and effectiveness issues relating to the product come into conclusion.

10. Performance Data:

Non-clinical data:

Non-clinical tests have been conducted to verify that the Beauty LED Mask meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device. The testing results demonstrate that the subject device complies with the following standards:

ANSI AAMI ES 60601-1, Medical electrical equipment Part 1: General A requirements for basic safety and essential performance
A IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1-11, 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

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IEC 60601-2-57, Medical Electrical Equipment Part 2-57: Particular requirements A for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use

Biocompatibility Test

The device has been tested for biocompatibility; it complies with the following standards.

ISO 10993-5, Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity
A ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

Clinical data: Not applicable.

Summary

Based on the non-clinical and clinical performance as documented in the system development, the subject devices were found to have a safety and effectiveness profile that is similar to the predicate device.

11. Conclusion

The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate that LED light therapy mask should perform as intended in the specified use conditions, and all the data demonstrate that the subject devices perform comparably to the predicate device that is currently marketed for the same intended use. In other words, the subject device (LED light therapy mask) is Substantial Equivalent to the predicate devices K200983, K221151, K162489 and K212155.

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.