The BEMER devices are noninvasive, fully reusable components such as electrodes), and have configurations allowing both patient / home and professional / office use. The subject device is specific to the LED based applications.

Low Level Light Therapy (LLLT) delivered via Light Emitting Diodes (LED) is a nonthermal technology used to modulate cellular activity with specific (nm) of light. Through photo biomodulation, photons are absorbed by chromophores within cells that are being treated. Various beneficial effects of LLLT delivered via light-emitting diodes at relatively low intensities have been reported, especially in indications where stimulation of healing, reduction of pain and inflammation, restoration of function, and skin rejuvenation are required. Light-emitting diode therapy (LED) is safe, nontoxic, and a noninvasive therapy for the treatment of Acne and the reduction of wrinkles and fine lines on the face.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for B.Light Clear Evo and B.Light Restore Evo devices. The document mainly focuses on establishing substantial equivalence to predicate devices based on technological characteristics and non-clinical testing. It does not contain information about explicit acceptance criteria or a dedicated clinical study proving the device meets specific performance criteria.

Therefore, many of the requested details, especially those related to clinical studies, will be marked as "Not provided in the document."

Here's an analysis of the available information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Explicitly stated)	Reported Device Performance (from "Comparison of Subject vs. Predicates" and "Non-clinical Testing")
B.Light Clear Evo (Acne treatment)
Wavelengths: 465 nm ± 20 nm (Blue) and 645 nm ± 20 nm (Red)	Reported: Blue: 465 nm ± 20 nm; Red: 645 nm ± 20 nm (Matches)
Irradiance source: LEDs	Reported: LEDs (Matches)
Power intensity (Red): 0.76 mW/cm²	Reported: Red: 0.76 mW/cm² (Matches)
Power intensity (Blue): 1.20 mW/cm²	Reported: Blue: 1.20 mW/cm² (Matches)
Treatment dose: 1 J/cm² per treatment	Reported: 1 J/cm² per treatment (Matches)
Treatment time: 8 minutes per day, 30 days	Reported: 8 minutes per day, 30 days (Matches)
Total treatment time: 240 minutes	Reported: 240 minutes (Matches)
B.Light Restore Evo (Wrinkle reduction)
Wavelengths: 860 nm ± 20 nm (IR) and 645 nm ± 20 nm (Red)	Reported: IR: 860 nm ± 20 nm; Red: 645 nm ± 20 nm (Matches)
Irradiance source: LEDs	Reported: LEDs (Matches)
Power intensity (Red): 0.56 mW/cm²	Reported: Red: 0.56 mW/cm² (Matches)
Power intensity (IR): 1.40 mW/cm²	Reported: IR: 1.40 mW/cm² (Matches)
Treatment dose: 1 J/cm² per treatment	Reported: 1 J/cm² per treatment (Matches)
Treatment time: 8 minutes per day, 30 days	Reported: 8 minutes per day, 30 days (Matches)
Total treatment time: 240 minutes	Reported: 240 minutes (Matches)
General Safety and Performance
Safety and EMC standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-57	Reported: Compliance with these standards (Matches)
Biocompatibility standards: ISO 10993-1	Reported: Compliance with ISO 10993-1 (Matches)
Software/Firmware/Microprocessor controlled	Reported: Yes (Matches, indicating successful functionality testing)
Home healthcare environment	Reported: Testing covered home healthcare (Matches, indicating suitability for intended use environment)
Non laser-light source equipment	Reported: Testing covered non laser-light source equipment (Matches)

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

Sample Size for Test Set: Not provided in the document. The document primarily relies on non-clinical performance testing and comparison to predicate devices, not clinical trials with patient test sets.
Data Provenance: Not applicable, as no clinical trial data for the subject device is presented. The document mentions non-clinical testing.

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)

Not provided in the document. This information would typically come from a clinical study, which is not detailed here for the subject device.

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

Not provided in the document, as no clinical study with a test set requiring adjudication is described.

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

No MRMC comparative effectiveness study was done or reported in this document. The devices are light therapy devices and do not involve "readers" or "AI assistance" in the context of diagnostic interpretation.

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

Not applicable. The devices are light therapy applicators, not diagnostic algorithms. The performance discussed is the physical characteristics and safety of the device itself.

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

For the non-clinical testing, the "ground truth" refers to established engineering standards, specifications, and regulatory requirements (e.g., IEC 60601 series for safety and EMC, ISO 10993-1 for biocompatibility). The document indicates that the device met these standards. No clinical ground truth (like pathology or outcomes data) for the subject device's performance in treating acne or wrinkles is presented in this document.

8. The sample size for the training set

Not applicable. The document describes a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. The document describes a physical medical device, not an AI/ML algorithm.

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 agency's name, "U.S. Food & Drug Administration."

September 23, 2023

Bemer INT. AG % Paul Dryden Consultant ProMedic Consulting LLC 131 Bay Point Dr. NE Saint Petersburg, Florida 33704

Re: K223919

Trade/Device Name: B.Light Clear Evo and B.Light Restore Evo 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 Dated: August 22, 2023 Received: August 22, 2023

Dear Paul Dryden:

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.

Tanisha L. Tanisha L. Hithe -S 2023.09.23 Hithe -S 11:46:08 -04'00'

Tanisha Hithe, MS, MHS 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)

K223919

Device Name

B.Light Clear Evo and B.Light Restore EVO

Indications for Use (Describe)

B.Light Clear Evo:

The device is intended for over-the-counter (OTC) use to treat patients with mild to moderate acne vulgaris on the face.

B.Light Restore Evo: — Use of light-based treatment to reduce wrinkles on the face.

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

Prescription Use (Part 21 CFR 801 Subpart D) XX Over-The-Counter Use (21 CFR 801 Subpart C)

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FORM FDA 3881 (6/20)

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Date Prepared:

22-Sep-2023

Paul Dryden

ProMedic, LLC

I Submitter

BEMER International, AG Austrasse 15 LIE-9495 Triesen, Liechtenstein Phone: +423-792-7386

Submitter Contact:

Sandra Schwarzenberger Quality Director

Submission Correspondent:

II Device Proprietary or Trade Name: Common/Usual Name:

Classification Name:

Regulation Product Code:

Predicate Device: III

Common/Usual Name: Classification Name:

Regulation Product Code:

Secondary Predicate Device:

Common/Usual Name: Classification Name:

Regulation Product Code:

Secondary Predicate Device:

Common/Usual Name: Classification Name:

Regulation Product Code:

Secondary Predicate Device: Common/Usual Name: Classification Name:

Regulation Product Code: BEMER Therapy Systems Evo Over-The-Counter Powered Light Based Laser For Acne Light Based Over The Counter Wrinkle Reduction Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology (21 CFR 878.4810) OHS and OLP

Shenzhen Kaiyan Medical Co. Ltd. (K202390) Aduro Light Beauty Mask Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology (21 CFR 878.4810) OHS and OLP

GlobalMed Technologies (K210948) Ominlux CLEAR Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology (21 CFR 878.4810) OLP

Johnson and Johnson Consumer (K180847) Neutrogena Light Therapy Acne Mask+ Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology (21 CFR 878.4810) OLP

Cellreturn Co. Ltd (K222377) LED Mask Platinum MD Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology (21 CFR 878.4810) OHS

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IV Device Description:

V Indications for Use:

B.Light Clear Evo:

The device is intended for over-the-counter (OTC) use to treat patients with mild to moderate acne vulgaris on the face.

B.Light Restore Evo: - Use of light-based treatment to reduce wrinkles on the face.

Environments of use: OTC in the home.

VI Comparison of Technological Characteristics and Performance with the Predicate

Table 1 below provides the summarized equivalence comparison of general intended uses/actions, specific indications for use, equivalence of key clinical and technical features between subject and predicate devices, along with a full listing of technical and conformance specifications.

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510(k) Summary Page 3 of 7

Table 1: Comparison of Subject vs. Predicates

	Subject Device		Predicate Device 1	Predicate Device 2	Predicate Device 3	Predicate Device 4
DeviceManufacturer	BEMER Int. AG	BEMER Int. AG	ShenzhenKaiyan Medical Co. Ltd.	GlobalMedTechnologies	Johnson & Johnson	Cellreturn Co.,Ltd
	BEMER LightTherapy SystemApplicator:B. Light Clear Evo	BEMER LightTherapy SystemApplicator:B.Light Restore Evo	Aduro Light Beauty MaskModel: MK-660, MK-66USBO, MK-66USBA,MK-66USBB, MK-02O,MK-02A, MK-02B	Omnilux CLEAR	Neutrogena LightTherapy Acne Mask+	LED Mask PlatinumMD
510(K) Number	-	-	K202390	K210948	K180847	K222377
DeviceClassificationName	Over the counterpowered light basedlaser for acne	Light based over thecounter wrinklereduction	Over the counter poweredlight based laser for acne(OLP)Light based over the counterwrinkleReduction (OHS)	Over the counterpowered light based laserfor acne vulgaris	Over the counterpowered light basedlaser for acne vulgaris	Light based over thecounter wrinklereduction
Device ProductCode	OLP	OHS	OHS, OLP, ILY	OLP	OLP	OHS
Regulation number	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810
Subject Device			Predicate Device 1	Predicate Device 2	Predicate Device 3	Predicate Device 4
Indications for Use	The device is intended	Use of light based	For MK-660, MK-	Tue Omnilux CLEAR	The Neutrogena Light	LED Mask Platinum
	for over-the-counter	treatment to reduce	66USBO, MK-02O:	acne facemask is an	Therapy Acne Mask+	MD is an over the
	(OTC) use to treat	wrinkles on the face.	The Aduro Light Beauty	over-the-counter device	is intended to emit	counter device that is
	patients with mild to		Mask (Model: MK-660,	intended to emit energy	energy in the red and	indicated for the
	moderate acne vulgaris		MK-66USBO, MK-02O)	in the red and blue region	blue region of the	treatment on the full
	on the face.		emits energy in the red and	of the light spectrum,	spectrum,	face wrinkles.
			blue region of the spectrum,	specifically indicated to	specifically indicated
			specifically indicated to treat	treat mild to moderate	to treat mild to
			full face wrinkles and/or	acne vulgaris on the face.	moderate acne on the
			mild to moderate acne.		face.
			For MK-66USBA, MK-
			02A:
			The Aduro Light Beauty
			Mask (Model: MK-
			66USBA, MK-02A) is
			intended to emit light in the
			blue region of the spectrum,
			specifically indicated to treat
			mild to moderate acne on the
			face.
			For MK-66USBB, MK-02B:
			The Aduro Light Beauty
			Mask (Model: MK-
			66USBB, MK-02B) is an
			over the counter device that
			is intended for the use in the
			treatment of full-face
			wrinkles.
Area of application	Face	Face	Face	Face	Face	Face
Wavelengths	Red: 645 nm ± 20 nm	IR: 860 nm ± 20 nm	Red: 640 nm ± 10 nm	Red: 630 nm ± 5 nm	Red: 620-640 nm	IR: 820 - 880 nm
	Blue: 465 nm ± 20 nm	Red: 645 nm ± 20 nm	Blue: 465 nm ± 10 nm	Blue: 412.5 nm ± 7.5 nm	Blue: 425-450 nm	Red: 630 - 690 nm
Irradiance source	LEDs	LEDs	LEDs	LEDs	LEDs	LEDs
Power intensity	Red: 0.76 mW/cm²	Red: 0.56 mW/cm²	Red+Blue: 30 mW/cm²	Red: 16 mW/cm²	Not publicly available	IR+Red: 2 mW/cm²
	Blue: 1.20 mW/cm²	IR: 1.40 mW/cm²		Blue: 28 mW/cm²
Treatment dose	1 J/cm² per treatment	1 J/cm² per treatment	Not publicly available	Red: 9.5 J/cm²	1.28 J/cm² per	0.96 J/cm²
				Blue: 16.8 J/cm²	treatment
					38.38 J/cm²
					Total 30 day dose
Treatment time	8 minutes per day	8 minutes per day	10 minutes per day,	10 Minutes	10 Minutes per day	8 min each time
	30 days	30 days	3 times per week	4 times per week	30 days
				6 weeks
	Subject Device	Predicate Device 1	Predicate Device 2	Predicate Device 3	Predicate Device 4
Total treatmenttime overrecommendedtreatment period	240 minutes	300 minutes	240 minutes	300 minutes	Not publicly available
Power supply	Control unit :Input voltage 100 -240V AC / 50 - 60 Hz, 15VDC / 2AApplicator:15 V AC	Control unit :Input voltage 100 -240 VAC / 50 - 60 Hz, 15 VDC/ 2AApplicator:15 V AC	For model MK-660, MK-66USBO:3.7 VDC 2600 mAh LithiumbatteryAdapter for charging only:Input: 100-240 VAC;Output: 5 VDC, 2AFor model MK-02O:3.7 VDC, 2600 mAhLithium battery	Not publicly available	Batteries	Main body input power:DC 5V, 2ABuilt-in battery:3.7 V, 2000 mAh
Safety and EMC	IEC 60601-1,IEC 60601-1-2,IEC 60601-1-6,IEC 60601-1-11,IEC 60601-2-57	IEC 60601-1,IEC 60601-1-2,IEC 60601-1-6,IEC 60601-1-11,IEC 60601-2-57	IEC 60601-1,IEC 60601-1-2,IEC 60601-1-6,IEC 60601-1-11,IEC 60601-2-57	IEC 60601-1,IEC 60601-1-2,IEC 60601-1-6,IEC 60601-1-11,IEC 60601-2-57	IEC 60601-1,IEC 60601-1-2,IEC 60601-1-6.IEC 60601-1-11,IEC 60601-2-57	IEC 60601-1.IEC 60601-1-2,IEC 60601-1-6,IEC 60601-1-11,IEC 60601-2-57
Biocompatibility	ISO 10993-1	ISO 10993-1	ISO 10993-1,ISO 10993-5,ISO 10993-10	ISO 10993-1,ISO 10993-5,ISO 10993-10	ISO 10993-1	Not publicly available
Weight	System (B.Box Evo):926 gApplicator:0.12 kg	System (B.Box Evo):926 gApplicator:0.12 kg	0.8 kg	Not publicly available	Not publicly available	Cradle:690 gMask:685 g
Dimensions,Applicator (W x Hx D)	12 cm x 12 cm x 2.5 cm	12 cm x 12 cm x 2.5 cm	Not publicly available	Not publicly available	Not publicly available	224 mm x 313 mm x172 mm
Dimensions,System (W x H xD)	210 mm x 150 mm x 43mm	210 mm x 150 mm x 43mm	Not publicly available	Not publicly available	Not publicly available	268 mm x 183 mm x240 mm
PowerConsumption(System)	30 Watt max.	30 Watt max.	Not publicly available	Not publicly available	Not publicly available	Not publicly available
	Subject Device		Predicate Device 1	Predicate Device 2	Predicate Device 3	Predicate Device 4
Input (System)	100 - 240 VAC 50 - 60 Hz,15V DC	100 - 240 VAC 50 - 60 Hz, 0.6 A	AC 100 - 240 V	Not publicly available	Not publicly available	AC 100 – 240 V, 50 – 60 Hz
Output (System)	15 V DC / 2 AOptional: Li-Ion battery	15 V DC / 2 AOptional: Li-Ion battery	DC5V - 2.1 ANickel metal hydride(NiMH) battery, 3.7 V, 2000 mAh.			DC 5V, 2A
Number of output modes (System)	1	1	1	1	1	1
Number of output channels and ports (System)	2 for each	2 for each	1	1	1	1
Software / Firmware / Microprocessor controlled	Yes	Yes	Yes	Yes	Yes	No
Sterilization	Not provided sterile	Not provided sterile	Not provided sterile	Not provided sterile	Not provided sterile	Not provided sterile

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510(k) Summary Page 4 of 7

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510(k) Summary

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510(k) Summary Page 6 of 7

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VII Substantial Equivalence

The B.LIGHT Clear and B.LIGHT Restore applicators have the same indications for use as the predicates, K202390, K210948, K180847 and K222377.

Intended Use/ Indications for Use

The BEMER Light System can only be used with the B.BOX Evo. The BEMER devices have similar indications for use, population and use environments as the predicates K202390, K210948 and K222377 but, similar to K180847.

Technological Characteristics

The technology of the LED's is identical to that of the predicate devices. The Power intensity (mW/cm2) is lower than that of the predicates, K202390, K210948 and K222377.

Principles of Operation

The principle of operation is similar to the predicates, K202390, K210948, K18947 and K222377.

Non-clinical Testing

Performance testing involved multiple measurements of:

o Software
Electrical / EMC O
O Home healthcare
Non laser-light source equipment O
O Biocompatibility

Discussion of Differences

The general clinical and functional equivalence between anatomic sites and applicator use between Bemer (B. LIGHT Restore, B.LIGHT Clear) and predicate - Aduro Light Beauty Mask, Omnilux Clear and LED Mask Platinum MD.

Unlike the other devices, the BEMER Light System is controlled by an external control unit while the Predicate Devices have an integrated the controller.

This difference does not raise different risks or concerns of safety and effectiveness compared to the predicate.

VIII Conclusion

Based non-clinical performance testing and comparison to the predicates, the B.LIGHT Clear and B.LIGHT Restore have demonstrated they are substantially equivalent for safety and effectiveness to the predicate devices.

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.

Indications for Use

K223919

B.Light Clear Evo and B.Light Restore EVO

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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW! *

Date Prepared:

I Submitter

II Device Proprietary or Trade Name: Common/Usual Name:

Predicate Device: III

Secondary Predicate Device:

Secondary Predicate Device:

IV Device Description:

V Indications for Use:

VI Comparison of Technological Characteristics and Performance with the Predicate

510(k) Summary Page 3 of 7

Table 1: Comparison of Subject vs. Predicates

510(k) Summary Page 4 of 7

510(k) Summary

510(k) Summary Page 6 of 7

VII Substantial Equivalence

Intended Use/ Indications for Use

Technological Characteristics

Principles of Operation

Non-clinical Testing

Discussion of Differences

VIII Conclusion

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

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