BABY QUASAR

K091467 · Silver Bay, LLC · ONE · Sep 17, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K091467
• Device Name: BABY QUASAR
• Applicant: Silver Bay, LLC
• Product Code: ONE · General, Plastic Surgery
• Decision Date: Sep 17, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Baby Quasar is a handheld dermatological device; utilizes an array of red and near-infrared light-emitting diodes (LEDs). Device emits narrow bands of light energy to provide heating to skin tissue. Operated by a physician or clinician; intended for use in a clinical setting. Device is placed directly on or held just above the skin surface. Output consists of light energy in the red and IR spectrum; intended to reduce periorbital wrinkles. Clinical benefit derived from thermal effects on skin tissue.

Clinical Evidence

Bench testing only. Testing included functional performance testing (power levels), electrical safety testing, and Electromagnetic Compatibility (EMC) testing. No clinical data provided.

Technological Characteristics

Handheld device; array of red and near-infrared LEDs. Energy source: AC power supply (UL listed). Dimensions: compact handheld. Connectivity: None. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for the treatment of periorbital wrinkles in patients requiring dermatological care. Prescription use only.

Regulatory Classification

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.

Predicate Devices

• New-U (K072459)

Submission Summary (Full Text)

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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 [phone] or 941-306-5812 Fax [phone] 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:

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.

- 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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- 6. 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.

- 8. 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 [phone] or [phone] 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.

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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