QUASAR CALYPSO

K111286 · Silver Bay, LLC · OLP · Jan 18, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K111286
• Device Name: QUASAR CALYPSO
• Applicant: Silver Bay, LLC
• Product Code: OLP · General, Plastic Surgery
• Decision Date: Jan 18, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Quasar Calypso C50 is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne vulgaris.

Device Story

Quasar Calypso C50 is a handheld, two-sided light therapy device; emits narrow-band blue light (405-420 nm) or red light (628 nm ± 10 nm). Powered by 12V wall-mount supply; operated via momentary switch; prevents simultaneous red/blue emission. Constructed of ABS plastic with polycarbonate lenses. Used for phototherapy to treat acne; intended for patient use. Device delivers light energy to skin; mechanism relies on spectral output for therapeutic effect. No software or automated analysis involved.

Clinical Evidence

No clinical data submitted. Bench testing only.

Technological Characteristics

ABS plastic housing with polycarbonate lenses. Dual-sided LED light source; blue (405-420 nm) and red (628 nm ± 10 nm). 12V wall-mount power supply. Non-sterile. Compliant with IEC/EN 60601-1 and IEC/EN 60601-1-2 standards.

Indications for Use

Indicated for treatment of mild to moderate acne vulgaris in patients.

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

• Quasar Blue Light Therapy System (K093963)
• Illumimed (PhotoActif) (K060792)
• Aklarus (Hill Labs) (K083183)
• Omnilux Clear-U (Photo Therapeutics, LTD) (K081307)

Submission Summary (Full Text)

{0}------------------------------------------------

## 510(k) Summary K | 286 1/3

Submission Date: March 15th, 2011

- 1. Submitter Information: AEGIS Regulatory, Inc. Robert T. Wagner 1131 Anthem View Lane Knoxville, TN 37922 Tel.: [phone] Email: [e-mail]
Silver Bay, LLC d/b/a Quasar Bio-Tech, Inc. For Manufacturer: Attn: Peter Nesbitt 1431 Tallevast Rd. Sarasota, FL 34231 Tel.: [phone] Email: [e-mail]

#### General Information: 2.

Classification Name: LED Phototherapy/Laser Instrument, Surgical, Powered 2.1 and Infrared lamp

- 2.2 Common/Usual Name: Quasar Calypso, C50
- 2.3 Proprietary/Trade Names: Quasar Calypso
- 2.4 Classification: Class II
- 2.5 Classification Number: 878.4810 and 890.5500
- 2.6 Product Codes: OLP

#### 3. Device Description:

The Silver Bay Quasar Calypso C50 is a visible light and/or heat source with high spectral purity. The device is made of ABS plastic with clear polycarbonate lenses covering the LED light sources. The device is two-sided with one side emitting narrow band blue light at 405 to 420 nm. The opposite side of the device emits red light at 628 nm +- 10 nm. The device is operated by a momentary switch, which allows the operator to select either the blue or red operation. The device does not allow the operator to select the red and blue light simultaneously.

The Quasar Calypso C50 uses a 12 volt wall mount power supply.

{1}------------------------------------------------

K111/286 2/3

#### 4. Indications / Intended Use:

The Quasar Calypso C50 is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne vulgaris.

#### 5. Predicate Device(s):

This device is substantially equivalent to the following predicate devices, which are currently in safe and effective commerce:

- 1. K093963 Quasar Blue Light Therapy System (Silver Bay, LLC)
- 2. K060792 Illumimed (PhotoActif)
- 3. K083183 Aklarus (Hill Labs)
- 4. K081307 Omnilux Clear-U (Photo Therapeutics, LTD)

#### 6. Technological Characteristics:

The Quasar Calypso C50 has the same technological characteristics, design, material, chemical composition, and energy source as the cited predicate devices.

#### 7. Performance Standards:

The device has been tested under and are in compliance with performance standards that have been established for such devices under Section 878 of the Federal Food, Drug, and Cosmetics Act. All electrical and radiological products made by the applicant have been OSHA/NRTL listed, and have received constituent marks and are in compliance with IEC/ EN 60601.

#### 8. Biocompatibility:

The patient contact material on the Quasar Calypso C50 is polycarbonate plastic and is the same material used in the cited predicate devices. The biocompatibility of this material is well known and accepted.

#### 9. Sterilization / Use:

The Quasar Calypso C50 is a non-sterile device, and therefore this section is not applicable Cleaning Instructions are in the User's Manual.

#### 10. Electromagnetic Compatibility and Electrical, Mechanical and Thermal Safety :

The device is in conformity with IEC/EN 60601-1-2000 and IEC/ EN 60601-1-2 Standards.

{2}------------------------------------------------

K111286 3/3

### 11. Clinical Studies:

No Clinical Data is submitted with this application

#### 12. Conclusion:

After an analysis of the safety, indications, intended uses, performance, features, design materials, power output, technological properties, treatment areas, treatment regimes and methods of operation, the manufacturer believes that no significant differences exist between the device and the predicates, therefore substantial equivalency is requested.

{3}------------------------------------------------

Image /page/3/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 and tail. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

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

Silver Bay, LLC d/b/a Quasar Bio-Tech, Incorporated % AEGIS Regulatory, Incorporated Mr. Robert T. Wagner 1131 Anthem View Lane Knoxville, Tennessee 37922

JAN 1 8 2012

Re: K111286

Trade/Device Name: Quasar Calypso C50 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: OLP Dated: December 22, 2011 Received: December 27, 2011

Dear Mr. Wagner:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed four becamer is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conninered pror to 1125 2011 and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic Aor (110) that to nevice, subject to the general controls provisions of the Act. The r ou may ; aterest of the Act include requirements for annual registration, listing of general connects provision practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can may be subject to back access as 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 I lease be advisou that I brit is a letermination that your device complies with other requirements of the Act that I Dr has made a averalations administered by other Federal agencies. You must of any I caelar statutes and regulaments, including, but not limited to: registration and listing (21 compy will and the recessed in the sold ); good manufacturing practice requirements as set

{4}------------------------------------------------

Page 2 – Mr. Robert T. Wagner

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maneting of substantial equivalence of your device to a legally prematication: The PDA miang of Eastification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific davice ion your as [phone]. Also, please note the regulation entitled, Colliact the Office of Comphalles and (21CFR Part 807.97). You may obtain Misolanding of Icrerchee to premaintentibilities under the Act from the Division of Small other general information on your responsionnes and its toll-free number (800) 638-204) or Manufacturers, michianonal and Consultat Proved. Eda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Erin Keith
for Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

### indications for use statement

510(k) Number: K11286

Device Name: Quasar Calypso C50

Indications for Use:

The Quasar Calypso C50 is intended to emit energy in the red and blue region of the spectrum, specifically intended to ennit energy in the red and blue regions
of the spectrum, specifically indicated to treat mild to moderate acne vulgaris.

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

# Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use _ (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96)

Neil R. Odek for mxm

Page of of I

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

. 510(k) Number K111286

Silver Bay LLC Quasar Calypso C50