The ClearFlash AC2100 is a compact, handheld device that delivers a controlled pulse of thermal energy to the skin for treating dermatological disorders, specifically, mild to moderate inflammatory acne. An acne lesion is treated by applying the tip of the ClearFlash AC2100 device to the skin area and pressing a pulse activation button that releases a controlled amount of thermal energy into the skin. After the pulse is delivered to the skin the ClearFlash AC2100 device is removed from the acne lesion and the treatment is complete. The treated area on the skin can then be cleaned with an over-the-counter astringent. The ClearFlash AC2100 device is powered by a 9V battery.

AI/ML Overview

The provided text describes the ClearFlash AC2100 Cosmetic System, a device for treating mild to moderate inflammatory acne. However, it does not contain specific acceptance criteria or a detailed study proving the device meets those criteria.

The submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than conducting extensive clinical efficacy trials typically associated with new medical device approvals.

Therefore, many of the requested
data points are not available in the provided document.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified	Laboratory bench top testing demonstrated that the ClearFlash AC2100 device performed similarly to the predicate devices.

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

Sample Size for Test Set: Not specified.
Data Provenance: The document only mentions "Laboratory bench top testing". No information on country of origin or whether it was retrospective or prospective is provided.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication method for the test set

Adjudication Method: Not specified.

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

MRMC Study: No. This device is a treatment system, not an AI-assisted diagnostic tool for human readers.

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

Standalone Performance: The device is a standalone treatment device. Its performance is assessed through its direct application for acne treatment, not as an algorithm. The text states "Laboratory bench top testing demonstrated that the ClearFlash AC2100 device performed similarly to the predicate devices," indicating an evaluation of the device itself.

7. The type of ground truth used

Type of Ground Truth: Not specified beyond "Laboratory bench top testing." For a treatment device, efficacy could be assessed by clinical improvement, but this document does not detail such evaluation. The substantial equivalence argument relies on comparing its mechanism to existing devices.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This document describes a physical medical device, not an AI algorithm that would typically require a training set.

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

Ground Truth for Training Set: Not applicable, as there is no mention of an AI algorithm or a training set.

Summary

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KII 1937-

FEB - 8 2012

510(k) Summary 5.

ClearFlash, Incorporated - ClearFlash AC2100 Cosmetic System

This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92(c).

Owner Name and Address	ClearFlash Technologies, Inc.901 South Mopac ExpresswayBarton Oaks Plaza One, Suite 300Austin, TX 78746(949) 949-295-6594 (Phone)(949) 334-0089 (Fax)
Contact Info	Joseph Neev2706 S. La Paz Rd. #108Aliso Viejo, CA 92656-3041(949) 295-6594 (Phone)(949) 334-0089 (Fax)
Date Prepared	June 30th, 2011
Device Trade Name	ClearFlash AC2100 Cosmetic System
Common Name	Acne Treatment Device
Classification Name	Class II - Laser instrument, surgical, powered (21 CFR 878.4810,Product Code OLP)
Predicate Devices and510(k) Numbers	ThermaClear Device (K060653)
	Zeno Acne Device (K043377)
	Radiancy ClearTouch Lite (K060411)

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Description of Device The ClearFlash AC2100 is a compact, handheld device that delivers a controlled pulse of thermal energy to the skin for treating dermatological disorders, specifically, mild to moderate inflammatory acne. An acne lesion is treated by applying the tip of the ClearFlash AC2100 device to the skin area and pressing a pulse activation button that releases a controlled amount of thermal energy into the skin. After the pulse is delivered to the skin the ClearFlash AC2100 device is removed from the acne lesion and the treatment is complete. The treated area on the skin can then be cleaned with an over-thecounter astringent. The ClearFlash AC2100 device is powered by a 9V battery. The ClearFlash AC2100 Cosmetic System is indicated for the Indications for Use treatment of individual acne pimples in persons with mild to moderate inflammatory acne. Performance Data Laboratory bench top testing demonstrated that the ClearFlash AC2100 device performed similarly to the predicate devices. Substantial Equivalence The ClearFlash AC2100 and predicate devices deliver thermal energy into the skin through different methods to treat mild to moderate inflammatory. Minor differences in the technological characteristics of the ClearFlash AC2100 device compared to predicate devices does not raise any new safety or efficacy issues. Therefore, the ClearFlash AC2100 device is substantially equivalent to the predicate devices. Based on the indications for use, technological characteristics, Conclusion performance testing and comparisons to predicate devices, the ClearFlash AC2100 has been shown to be safe and effective for its

intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

FEB - 8 2012

ClearFlash Technologies, Inc. % Mr. Joseph Neev Regulatory Consultant to CFT, Inc. 2706 S. La Paz Road, #108 Aliso Viejo, California 92656-3041

Re: K111937

Trade/Device Name: ClearFlash AC2100 Cosmetic System 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: OLP Dated: January 19, 2012 Received: January 23, 2012

Dear Mr. Neev:

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. 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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Page 2 - Mr. Joseph Neev

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkersof Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement 4.

510(k) Number (if known):	K111937
Device Name:	ClearFlash AC2100 Cosmetic System
Indications for Use:	The ClearFlash AC2100 Cosmetic System is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

Prescription Use ____________ AND/OR Over-The Counter Use ____________ X

(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(Please do Not Write Below This Line-Continue on Another Page IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

NelfROgden for mxm

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111937

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.