This unit is a battery type wireless LED curing light. User can adjust light intensity and time by selecting six program modes. Both of Dr's Light PRIME and Dr's Light Choice are characterized by high power intensity, slim head height, large irradiation area (12mm), adjustable intensity power, highly readable color touch screen, 360° twistable head and big capacity of the battery.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental curing light, CL-DP40 (Dr's Light PRIME) / CL-DP40 (Dr's Light CHOICE). This submission aims to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the technical specifications of the predicate device, particularly the primary predicate, "Dr's Light 2" (K173157). The subject device is deemed substantially equivalent because its performance metrics are comparable or superior to the predicate.

Acceptance Criteria (from Primary Predicate)	CL-DP40 (Dr's Light PRIME) / CL-DP40 (Dr's Light CHOICE) Reported Performance
Operational Modes: 7 Modes	6 Modes (Note: The submission states this difference "does not raise a question in safety and performance")
Light Source: 8W LED	8W LED
Power Source: Battery 3.7V	Battery 3.7V
Wavelength Range: 400nm-490nm	400nm-490nm (Dr's Light PRIME), 440nm-490nm (Dr's Light CHOICE)
Accessories: Guide Tip, Shield	Guide Tip, Shield
Material Composition: Glass Guide Tip	Glass Guide Tip
Light Intensity: Max 1600W/cm²	Max 1600W/cm²
Peak Wavelength: 460nm & 405nm	460nm & 405nm
Depth of Cure: 2.3mm (avg.)	2.3mm (avg.)
Electrical Safety: IEC 60601-1	IEC 60601-1
EMC & EMI: IEC 60601-1-2	IEC 60601-1-2

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of a clinical study with patients or samples. Instead, non-clinical tests were performed on the device itself.

Sample Size: Not explicitly stated for each test (e.g., how many devices were tested for depth of cure, electrical safety).
Data Provenance: The tests were non-clinical, likely conducted in a laboratory setting. There is no information regarding country of origin or whether they were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a dental curing light, and the evaluation did not involve human interpretation of medical images or data requiring expert-established ground truth. The "ground truth" for its performance is based on established engineering and materials science principles and measurements (e.g., light intensity, depth of cure).

4. Adjudication method for the test set

Not applicable, as there was no test set requiring expert adjudication for ground truth.

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

Not applicable. This document is for a dental curing light, not an AI-powered diagnostic device. No MRMC study was conducted.

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

Not applicable. This device does not use an algorithm or AI. It is a manually operated medical device.

7. The type of ground truth used

The "ground truth" for the performance evaluation relies on:

Physical measurements: For parameters like light intensity, peak wavelength, and depth of cure, standardized measurement techniques appropriate for dental curing lights would have been used. These measurements serve as the factual basis for performance.
Engineering standards: Compliance with standards like IEC 60601-1 (Electrical Safety) and IEC 60601-1-2 (EMC & EMI) serves as the "ground truth" for electrical safety and electromagnetic compatibility.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI, so there is no training set.

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

Not applicable, as there is no training set.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 4, 2023

Good Doctors Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant Lk Consulting Group USA, Inc. 18881 Von Karman Ave. STE 160 Irvine. California 92612

Re: K223507

Trade/Device Name: CL-DP40 (Dr's Light PRIME), CL-DP40 (Dr's Light CHOICE) Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator For Polymerization Regulatory Class: Class II Product Code: EBZ Dated: June 5, 2023 Received: June 5, 2023

Dear Priscilla Chung:

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.

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

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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,

Bobak Shirmohammadi -S

For Michael E. Adjodha, M. ChE., CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental 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)

K223507

Device Name

CL-DP40 (Dr's Light PRIME)/ CL-DP40 (Dr's Light CHOICE)

Indications for Use (Describe)

CL-DP40 (Dr's Light PRIME)/CL-DP40 (Dr's Light CHOICE)is a hand held LED polymerization light intended to cure dental composites using visible light.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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K223507

510(k) Summary

This summary of 510(K) information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: 11/21/2022

1. Submitter

Good Doctors Co., Ltd. #208, B-dong, 283 Bupyeong-daero, Bupyeong-gu, Incheon 21315, Republic of Korea

2. U.S Agent/Contact Person

Priscilla Chung LK Consulting Group USA, Inc. 18881 Von Karman STE 160, Irvine CA 92612 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com

3. Device

. Trade Name: CL-DP40 (Dr's Light PRIME)/ CL-DP40 (Dr's Light CHOICE)
Common Name: Ultraviolet Activator
Classification Name: Ultraviolet Activator for Polymerization ●
Product Code: EBZ ●
. Classification regulation: 21CFR 872.6070

4. Predicate Device:

Primary Predicate Device:
- Dr's Light 2 by Good Doctors Co., Ltd. (K173157)
Reference Predicate Devices: Bluephase by Ivoclar Vivadent (K033520) LED Turbo by Apoza Enterprise Co., Ltd. (K040618)

5. Description:

This unit is a battery type wireless LED curing light. User can adjust light intensity and time by selecting six program modes. Both of Dr's Light PRIME and Dr's Light Choice

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are characterized by high power intensity, slim head height, large irradiation area (12mm), adjustable intensity power, highly readable color touch screen, 360° twistable head and big capacity of the battery.

6. Indication for use:

CL-DP40 (Dr's Light PRIME)/CL-DP40 (Dr's Light CHOICE)is a hand held LED polymerization light intended to cure dental composites using visible light.

7. Basis for Substantial Equivalence

The subject device CL-DP40 (Dr's Light PRIME) / CL-DP40 (Dr's Light CHOICE) incorporates the same intended use with the predicate devices. The devices are similar in device design and the structure.

The technical specifications between the subject device and the primary predicate device are identical. The difference is that the subject device has 6 modes and the primary predicate device has 7 modes. However, we believe this difference does not raise a questions in safety and performance since the technical specifications between the devices are the same.

	Subject Device	Primary PredicateDevice	Reference PredicateDevice 1	Reference PredicateDevice 2
510(K) #	N/A	K173157	K033520	K040618
Device Name	CL-DP40 (Dr'sLight PRIME)CL-DP40 (Dr'sLight CHOICE)	Dr's Light 2	Bluephase	LED Turbo
Manufacturer	Good Doctors Co.,Ltd.	Good Doctors Co.,Ltd.	Ivoclar Vivadent	Apoza Enterprise Co.,Ltd.
Product Code	EBZ	EBZ	EBZ	EBZ
Intended for Use	CL-DP40 (Dr'sLight PRIME)/CL-DP40 (Dr'sLight CHOICE) isa hand held LEDpolymerizationlight intended tocure dentalcomposites usingvisible light.	Dr's Light 2 is a handheld LEDpolymerization lightintended to curedental compositesusing visible light.	Bluephase® is a handheld LEDpolymerization lightintended to cure dentalcomposites usingvisible light.	The LED Turbo is adental curing light that isdesigned for use in theoptic polymerization ofdental resins andactivation of bleachingmaterials.
Device Design1. OperationalModes2. Light Source3. Power Source4. Wave lengthrange5. Accessories	1. 6 Modes2. 8W LED3. Battery 3.7V4. 400nm-490nm(Dr's Light PRIME)440nm-490nm(Dr's Light Choice)5. Guide Tip,Shield	1. 7 Modes2. 8W LED3. Battery 3.7V4. 400nm-490nm5. Guide Tip, Shield	1. 3 Modes2. 8W LED3. Battery 7.2V4. 430nm-490nm5. Guide Tip, Shield	1. 3 Modes2. 5W LED3. Battery 7.2V4. 440nm-490nm5. Guide Tip, Cone
Composition ofMaterials	Glass Guide Tip	Glass Guide Tip	Glass Guide Tip	Glass Guide Tip

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Technicalspecification1. Lightintensity2. PeakWavelength3. Depth of cure	Max 1600W/cm2460nm & 405nm2.3mm(avg.)	Max 1600W/cm2460nm & 405nm2.3mm(avg.)	Max 1100mW/cm2460nm2.1mm(avg.)	Max 1100mW/cm2460nm2.1nm(avg.)
Electrical Safety	IEC60601-1	IEC 60601-1	-	-
EMC & EMI	IEC 60601-1-2	IEC 60601-1-2	-	-

8. Non-Clinical Testing

· Depth of curing test
Electrical Safety and EMC tests in accordance with IEC 60601-1 and 60601-1-2

9. Conclusion

The subject devices and the predicate device have the same intended use and have the same technological characteristics.

Overall, CL-DP40 (Dr's Light PRIME)/CL-DP40 (Dr's Light CHOICE) has the following similarities to the predicate device:

- have the same intended use,
- use the same operating principle,
- incorporate similar design,
- have the same technological characteristics

Based on the similarities, we conclude that the subject device is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 872.6070 Ultraviolet activator for polymerization.

(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.