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 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.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided 510(k) summary, explicit performance acceptance criteria and corresponding reported device performance for treating acne vulgaris are not provided. The document focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and safety standards, rather than direct clinical performance metrics.

Acceptance Criteria	Reported Device Performance
No explicit clinical acceptance criteria were stated for acne treatment efficacy.	No clinical performance data related to acne treatment efficacy was presented.
Technological Characteristics Equivalence: The device should have the same technological characteristics, design, material, chemical composition, and energy source as the cited predicate devices.	The Quasar Calypso C50 is stated to have the "same technological characteristics, design, material, chemical composition, and energy source as the cited predicate devices."
Electrical Safety Standards Compliance: Compliance with performance standards under Section 878 of the Federal Food, Drug, and Cosmetics Act, and IEC/EN 60601-1-2000 and IEC/EN 60601-1-2 Standards.	The device is stated to be "in compliance with performance standards that have been established for such devices under Section 878 of the Federal Food, Drug, and Cosmetics Act" and "in conformity with IEC/EN 60601-1-2000 and IEC/EN 60601-1-2 Standards."
Biocompatibility: Patient contact material (polycarbonate plastic) is well-known and accepted.	The patient contact material is polycarbonate plastic, which is stated to be "the same material used in the cited predicate devices" and its biocompatibility is "well known and accepted."

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

Test Set Sample Size: Not applicable. No clinical studies were conducted or submitted.
Data Provenance: Not applicable. No clinical data was used.

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

Not applicable. No clinical studies were conducted, and therefore, no expert-established ground truth for a test set was required.

4. Adjudication Method for the Test Set

Not applicable. No clinical studies were conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was NOT done.
Effect size of human reader improvement with AI vs. without AI assistance: Not applicable, as no such study was conducted.

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

No, a standalone performance study was NOT done. The device is a physical light therapy device, not an algorithm.

7. The Type of Ground Truth Used

Not applicable. No clinical efficacy data was submitted, and thus no ground truth for clinical performance was established in the context of this submission. The "ground truth" for the submission's purpose was the established safety and efficacy of the predicate devices and compliance with relevant safety standards.

8. The Sample Size for the Training Set

Not applicable. This is a medical device (light therapy) submission, not an AI/machine learning algorithm. Therefore, there is no "training set."

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

Not applicable. As there is no training set mentioned, there is no ground truth established for a training set.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The provided 510(k) summary explicitly states: "No Clinical Data is submitted with this application."

Instead of conducting clinical studies to prove direct efficacy for treating mild to moderate acne vulgaris, the submission relies on demonstrating substantial equivalence to existing predicate devices already on the market. The "proof" that the device meets its implicitly accepted performance (i.e., effectiveness for its intended use) and safety criteria is based on the following:

Technological Equivalence: The device shares the "same technological characteristics, design, material, chemical composition, and energy source" as the identified predicate devices (K093963 Quasar Blue Light Therapy System, K060792 Illumimed, K083183 Aklarus, K081307 Omnilux Clear-U). This implies that if the predicates are safe and effective, and the new device is technologically similar, it is also assumed to be safe and effective for the same indications.
Compliance with Recognized Standards: The device's compliance with established performance standards under Section 878 of the Federal Food, Drug, and Cosmetics Act, and electrical and safety standards like IEC/EN 60601-1-2000 and IEC/EN 60601-1-2. This addresses the safety aspect of the device.
Biocompatibility of Materials: The use of polycarbonate plastic for patient contact, a material already "well known and accepted" and used in predicate devices, addresses biocompatibility concerns.

In essence, the "study" proving the device meets the acceptance criteria is a comparative analysis against predicate devices and adherence to relevant safety and performance engineering standards, rather than a clinical trial demonstrating efficacy in patients.

Summary

{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.: 865-982-5552 Email: bob@fdalistingconsultants.com
  Silver Bay, LLC d/b/a Quasar Bio-Tech, Inc. For Manufacturer: Attn: Peter Nesbitt 1431 Tallevast Rd. Sarasota, FL 34231 Tel.: 941-306-5812 Email: peter@guasarpro.com

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 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)
1. K060792 Illumimed (PhotoActif)
1. K083183 Aklarus (Hill Labs)
1. 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 (240) 276-0115. 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)

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

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.