The "Quasar Blue" Blue Light Therapy System is intended to provide photo therapeutic light to the body. The "Quasar Blue" Blue Light Therapy System is generally indicated to treat dermatological conditions. The "Quasar Blue" Blue Light Therapy System is specifically indicated to emit visible blue/violet light to treat mild to moderate inflammatory acne vulgaris.

Device Description

The "Quasar Blue" Blue Light Therapy System is identical to the company's previously cleared Quasar Blue Light Therapy System (K072767). Only the Operators Manual and the Patient Treatment Protocol have been modified to reflect the home use of the product. These documents have been amended to allow for an Over the Counter use. The Quasar Blue Light Therapy System has similar physical and technical characteristics to the predicate devices.

AI/ML Overview

The provided text describes a 510(k) submission for the "Quasar Blue Light Therapy System." However, it does not contain any information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert qualifications.

The document primarily focuses on:

Device Identification and Classification: Trade name, common name, classification, product code.
Predicate Device: Stating that the device is substantially equivalent to a previously cleared device (K072767) with only modifications to the operator's manual and patient treatment protocol for home use.
Indication for Use: "To emit visible blue/violet light to treat mild to moderate inflammatory acne vulgaris."
Basis for Substantial Equivalence: Claiming substantial equivalence based on intended use, principle of operation, and overall technological characteristics compared to existing marketed devices.
FDA Review Outcome: The FDA's letter granting substantial equivalence based on the provided information, emphasizing general controls and other regulatory requirements.

Therefore, I cannot fulfill your request for the specific details outlined, as those are not present in the provided text.

Based on the provided text, the following information is available:

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

Acceptance Criteria: Not specified in the document.
Reported Device Performance: Not specified in the document. The document states, "All necessary testing has been performed for the Quasar Blue Light Therapy System to assure substantial equivalence to the predicate devices." However, no specific performance data or metrics are provided.

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

Not specified in the document.

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 specified in the document.

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

Not specified in the document.

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 specified in the document. This is a light therapy system, not an AI diagnostic device, so an MRMC study and AI enhancement would not be applicable.

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

Not specified in the document. This is a light therapy system, not an algorithm.

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

Not specified in the document. Given this is a light therapy device, "ground truth" in the context of diagnostic accuracy is not directly applicable. Performance would typically relate to clinical efficacy in treating acne.

8. The sample size for the training set

Not applicable as this is a medical device, not an AI algorithm requiring a training set.

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

Not applicable as this is a medical device, not an AI algorithm.

Summary

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1. 510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

APPLICANT:	Silver Bay LLC
TRADE NAME:	Quasar Blue Light Therapy system	AUG 27 2010
COMMON NAME:	Light Therapy system
CLASSIFICATION NAME:	Over-the-counter powered light based laser for acne
DEVICE CLASSIFICATION:	Class II, under 21 CFR, 878.4810,
PRODUCT CODE	Product Code OLP
PREDICATE DEVICES:	The "Quasar" Blue Light System for home use is identicalto the company's previously cleared Quasar Blue LightTherapy System (K072767). Only the Operators Manual andthe Patient Treatment Protocol have been modified toreflect the home use of the product. These documentshave been amended to allow for an Over the Counter

Substantially Equivalent To:

The Quasar Blue Light Therapy System is substantially equivalent in intended use, principal of operation and technological characteristics to the legally marketed Quasar Blue Light Therapy System (K072767).

Description of the Device Subject to Premarket Notification:

Indication for Use

Indication for Use:

Technical Characteristics:

The Quasar Blue Light Therapy System has similar physical and technical characteristics to the predicate devices.

Performance Data:

All necessary testing has been performed for the Quasar Blue Light Therapy System to assure substantial equivalence to the predicate devices.

Silver Bay LLC Quasar Blue Light Therapy system

Premarket Notification

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Basis for Determination of Substantial Equivalence:

Upon reviewing the safety and effectiveness information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the Quasar Blue Light Therapy System is determined by Silver Bay to be substantially equivalent to existing legally marketed devices.

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Silver Bay LLC Quasar Blue Light Therapy system

Premarket Notification

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three swooping lines representing its wings and body. 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

Silver Bay LLC % Mr. Peter Nesbitt 1431 Tallevast Road Sarasota, Florida 34243

AUG 2 7 2010

Re: K093963

Trade/Device Name: Quasar Blue Light Therapy 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: August 18, 2010 Received: August 18, 2010

Dear Mr. Nesbitt:

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.

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

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Page 2 - Mr. Peter Nesbitt

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 (OS) 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/CDRH0ffices/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". (21.CER 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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Mark A. Milliken

Mark N. Melkerson 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

INDICATIONS FOR USE STATEMENT

AUG 2 7 2010

510(k) Number (if known): _________________

Device Name: "Quasar Blue" Light Therapy System

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use X (Optional Format 1-2-96)

Mark M. Mulhern

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

K093963

Silver Bay LLC Quasar Blue Light Therapy system

510(k) Number

Premarket Notification

Page __ of

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.