This is a hand held device intended to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

Device Description

The Baby Quasar consists of a collection of red and near infrared diodes [LEDs], packaged in a compact handheld device. The device has a head containing the led array, momentary switch, and indicator light.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text for the Baby Quasar Infrared Lamp:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Intended Use	Treatment of periorbital wrinkles
Technological Characteristics	Utilizes red and infrared diodes (LEDs) to provide narrow bands of light energy. Power densities and wavelengths are "nearly identical" to predicate devices.
Safety	Functional performance testing (power levels), electrical safety testing, and Electromagnetic Compatibility Testing (EMC) completed. AC power supply is UL listed. No new safety issues raised.
Effectiveness	Performs as intended. "The performance achieved by these devices are the same" (as predicate devices). No new effectiveness issues raised.
Regulatory Classification	Similar use and technological characteristics to predicate devices; deemed "substantially equivalent" to predicate devices (New-U K072459) for treatment of periorbital wrinkles.

Note: The document focuses on demonstrating substantial equivalence to a predicate device rather than setting specific quantitative acceptance criteria or reporting detailed clinical performance metrics like wrinkle reduction percentages or photographic evidence. The "reported device performance" is largely framed by its similarity to the predicate device.

2. Sample Size Used for the Test Set and the Data Provenance

The provided document does not mention any clinical test set involving human subjects for evaluating the effectiveness of the Baby Quasar device. The testing described primarily covers functional performance, electrical safety, and EMC of the device itself.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

As there's no mention of a clinical test set with human subjects, there's no information about experts used to establish ground truth.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set using human subjects 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

Not applicable. This device is an infrared lamp for wrinkle reduction, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI-related metrics are relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

For the device's functional and safety testing, the ground truth would be based on established engineering and safety standards (e.g., power level specifications, electrical safety criteria, EMC standards).

For the intended effect (wrinkle reduction), the document states an equivalence to predicate devices, which would have historically demonstrated effectiveness. However, no specific clinical ground truth (e.g., expert consensus on wrinkle severity, photographic analysis) is described for the Baby Quasar itself in this submission.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML product that utilizes a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set mentioned.

Summary

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510(K) Summary K091467.

This summary of 510(k) summary information is being submitted in accordance with the requirements of 21 CFR Part 807.92 for the Baby Quasar Over the Counter Wrinkle Reduction Infrand Lamp.

This summary is submitted by:

Silver Bay, LLC 1431 Tallevast Rd. Sarasota, FL 34243 Tel 1-800-944-1523 or 941-306-5812 Fax 941-306-5816 Contact: Peter Nesbitt President, peter(@quasarpro.com Date prepared: 27 July 2010

SEP 1 7 2010

1. Device Identification:
  Trade/Proprietary Name: Common/Usual Name: Classification Names:

Baby Quasar Light Therapy Device Wrinkle Reduction Device, 21 CFR § 878.4810

2 Predicate Devices:

The Baby Quasar Lamp is substantially equivalent to other devices on the market, such as the over the counter New-U (K072459) Photo Therapeutics Inc.

3. Indications for Use:

The Baby Quasar is a hand held device intended to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

4. Description of the Device:

5 Summary of the technological characteristics of the device Compared to predicate devices:
The Baby Quasar and the above referenced predicate New-U device are Wrinkle Reduction Devices as defined in 21 CFR § 878.4810. These devices utilize red and infrared diodes [LEDs], to provide narrow bands of light energy to reduce wrinkles. The performance achieved by these devices are the same, using nearly identical power densities and wavelengths. The devices are handheld, and intended to be placed directly on the skin or held just over the skin to provide the heating. The predicate device is OTC (Over the counter) whereas ours is a prescription device.

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1. Testing:
  Testing of the Baby Quasar included functional performance testing (power levels), electrical safety testing, and Electromagnetic Compatibility Testing (EMC). The AC power supply is UL listed.
Rx or OTC: 7.
The Baby Quasar is an Rx only device. The labeling, instructions, and User Operations (21 CFR § 801.60 and 61), are designed for physician understanding and use. The predicate device is OTC.
1. Conclusions:
  Based upon the testing and comparison to the predicate devices, the Baby Quasar has the same intended uses, with similar technological characteristics as the predicate devices. The system performs as intended and does not rarse any new safety or effectiveness issues.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Public Health Service

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

Silver Bay, LLC % Kamm & Associates Mr. Daniel Kamm, P.E. 333 Milford Road Deerfield, Illinois 60015

SEP 1 7 2010

Re: K091467

Trade/Device Name: Baby Quasar Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general surgery and plastic surgery and in dermatology Regulatory Class: Class II Product Code: ONE Dated: September 09, 2010 Received: September 15, 2010

Dear Mr. Kamm:

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. Daniel Kamm, P.E.

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. Melkerson

Mark N: Melk 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

K.091467

SEP 1 7 2010

510(k) Number (if known): K091467.

Device Name:__Baby Quasar

Indications For Use:

This is a hand held device intended to emit energy in the red and IR region of the spectrum for use in
dermatology for the treatment of paris hits been by dermatology for the treatment of periorbital wrinkles.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use_ (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 (ODE)

Page 1 of 1
Nil R.P. Ogden for mxn

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

510(k) Number K091467

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.