The Absolute White Light is intended for use by the end consumer. The Absolute White Light is a battery operated, hand held device that contains a hun vosible light in the 400 nanometer spectrum, which can penetrate the tooth and activate the photoactive substances within the tooth yielding a minimal amount of heat. Built in safety features include automatic light shut off after two minutes and "Light Guard" that prevents light exposure to the user's eyes.

AI/ML Overview

The provided document describes the Absolute White Light, a device intended to provide a light source for bleaching teeth. However, it does not include a study that proves the device meets specific acceptance criteria in terms of efficacy or performance on human subjects for tooth whitening. Instead, the document focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and safety standards.

Here's a breakdown based on your request, highlighting what is present and what is absent:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of clinical performance (e.g., a specific percentage improvement in tooth shade) for the Absolute White Light. Instead, it relies on demonstrating that the device is "substantially equivalent" to a legally marketed predicate device (Dentovations Luster Whitening System) in terms of its intended use and technical characteristics.

The "performance data" section primarily refers to compliance with quality system regulations and safety standards, not clinical efficacy data.

Table of Comparison with Predicate Device (acting as the basis for "performance" as substantial equivalence):

Feature	Absolute White Light	Dentovations Luster Light (Predicate)	Acceptance Criteria Implied by Equivalence	Reported Device Performance (Absolute White Light)
Intended Use	Light source, Teeth Bleaching	Light source, Teeth Bleaching	Same as Predicate	Light source, Teeth Bleaching
Method of Use	Hand Held	Hand Held	Same as Predicate	Hand Held
Treatment Time	2 minutes	2 minutes	Same as Predicate	2 minutes
Treatment(s)	As Needed	As Needed	Same as Predicate	As Needed
Area of Use	Oral Cavity	Oral Cavity	Same as Predicate	Oral Cavity
Light Source	LED	LED	Same as Predicate	LED
Wavelength of Light	400 nm	350 – 700 nm	Within (or close to) Predicate's range	400 nm (within predicate range)
Color of Light	Blue	Blue	Same as Predicate	Blue
Presentation	Non-Sterile	Non-Sterile	Same as Predicate	Non-Sterile

Additional "Performance Data" (Compliance, not clinical efficacy):
The device is manufactured in compliance with:

Quality System Regulations (21 CFR 820)
DIN EN ISO13485:2003
DIN EN ISO 9001:2000
EN 61000-6-1 Electromagnetic compatibility (EMC) Part 6-1: Immunity standard for residential, commercial and light-industrial environments
EN61000-6-3 Electromagnetic compatibility (EMC) Part 6-3: Emission standard for residential, commercial and light-industrial environments

Study Details (or lack thereof)

Based on the provided text, there is no specific clinical study or performance study presented that directly proves the device's efficacy in terms of tooth whitening (e.g., changes in shade). The submission relies on demonstrating substantial equivalence to a predicate device, implying that since the predicate device is already cleared for use, a device with similar characteristics and intended use is also safe and effective.

Therefore, the following points cannot be addressed with the provided text, as no such study is described:

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, no clinical test set described for efficacy.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no clinical test set described for efficacy.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, no clinical test set described for efficacy.
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 is not an AI/imaging diagnostic device. No MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, this is not an AI/imaging diagnostic device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, no clinical ground truth for efficacy was established or reported. The "ground truth" for regulatory clearance was the substantial equivalence to the predicate device based on technical specifications and safety standards.
The sample size for the training set: Not applicable, no machine learning model or training set is described.
How the ground truth for the training set was established: Not applicable, no machine learning model or training set is described.

Conclusion from the document:

The regulatory approval (K110888) was granted based on the determination of "substantial equivalence" of the Absolute White Light to the predicate device (Dentify Luster Whitening System, K042153). This means the FDA concluded that the new device has the same intended use and similar technological characteristics to a device already on the market and does not raise different questions of safety and effectiveness. The "performance data" provided focuses on manufacturing quality systems and adherence to electromagnetic compatibility (EMC) standards, not on clinical performance demonstrating tooth whitening efficacy in human subjects.

Summary

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K1108888

ATTACHMENT II

510(K) SUMMARY (AS PER 21 CFR 807.92)

JAN 1 2 2012

I. GENERAL INFORMATION

Device Generic Name: Whitening Light

Trade Name: Absolute White Light

Device Classification: Heat Source for Bleaching Teeth (21 CFR 872.6475)

Product Code: EEG

Applicant Name and Address:

Dr. Fresh, Inc. 6645 Caballero Blvd. Buena Park, CA 90620

Contact Name: Gary Pendyala 714-690-1573

Date of Submission: December 15, 2011

510(k) Number: K110888

II. Device Description

III. Indications for Use

The Absolute White Light emits visible blue light in the 400 nanometer spectrum and is intended to provide a light source for bleaching teeth.

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IV. Predicate Device

The Absolute White Light is substantially equivalent to other tooth whitening lights currently in commercial distribution such as the Dentify while in the Luster Whitening System (formerly South Beach Smile Light and Klear Action) as cleared by the FDA under Accession Number K042153).

Summary of the Technical Characteristics of the Absolute White Light as > Related to the Referenced Predicate Devices.

The Absolute White Light and the aforementioned predicate device are light sources for bleaching teeth as defined in 21 CFR 872.6475.

The Absolute White Light is a conventional tooth whitening light which works in conjunction with a bleaching agent to provide a light which which works in The Absolute White Light has the same intended use and similar technological characteristics to the predicate device.

Product	Absolute WhiteLight	Dentovations LusterLight
Intended Use	Light source TeethBleaching	Light source, TeethBleaching
Method of Use	Hand Held	Hand Held
TreatmentTime	2 minutes	2 minutes
Treatment(s)	As Needed	As Needed
Area of Use	Oral Cavity	Oral Cavity
Light Source	LED	LED
Wavelength ofLight	400 nm	350 – 700 nm
Color of Light	Blue	Blue
Presentation	Non-Sterile	Non-Sterile

VI. Performance Date

The device is manufactured in compliance with Quality System meeting the requirements of the Food and Drug Ministration's Quality System Regulations (21 CFR 820), DIN EN ISO13485:2003 and / or DIN EN ISO 9001:2000. The device is manufactured to comply with recognized consensus and safety standards listed below:

EN 61000-6-1 Electromagnetic compatibility (EMC) Part 6-1: . Generic standards - Immunity standard for residential, commercial and light-industrial environments

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EN61000-6-3 Electromagnetic compatibility (EMC) Part 6-3: . Generic standards ~ Emission standard for residential, commercial and light-industrial environments

Conclusion

Pursuant to the testing and comparison to the predicate device, the Absolute White Light has the same intended use, with similar function and performance characteristics. Therefore, the Company believes that the Absolute White Light is substantially equivalent to currently marketed devices, such as the Dentovations Luster Whitening System.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are 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

Dr. Fresh, Incorporated C/O Ms. Joyce Heinrich Regulatory Consultant Texas Applied Biomedical Services 12101 Cullen Boulevard Houston, Texas 77047-1131

JAN 1 2 2012

Re: K110888

Trade/Device Name: Absolute White Light Regulation Number: 21 CFR 872.6475 Regulation Name: Heat Source for Bleaching Teeth Regulatory Class: I Product Code: EEG Dated: December 20, 2011 Received: January 5, 2012

Dear Ms. Heinrich:

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- Ms. Heinrich

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 vours.

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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ATTACHMENT I

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K110888

Device Name:

Absolute White Light

Indications for Use:

The Absolute White Light emits visible blue light in the 400 nanometer spectrum and is intended to provide a light source for bleaching teeth.

AND/OR Over the Counter Use: Prescription Use: J X (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODPE)

Susan Ranne

(Division Sign-Off) Division of Anesthesiology, General Hospltal Infection Control, Dental Devices

510(k) Number: JC110555

Regulation Number and Section

§ 872.6475 Heat source for bleaching teeth.

(a)
Identification. A heat source for bleaching teeth is an AC-powered device that consists of a light or an electric heater intended to apply heat to a tooth after it is treated with a bleaching agent.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.