(247 days)
Not Found
No
The summary describes a light therapy system and explicitly states that no AI, DNN, or ML is mentioned.
Yes
The device is intended to provide phototherapeutic light to the body and specifically indicated to treat mild to moderate inflammatory acne vulgaris, which falls under the definition of a therapeutic purpose.
No
Explanation: The device is described as a "Blue Light Therapy System" intended to treat dermatological conditions, specifically acne vulgaris, by emitting phototherapeutic light. It is a therapeutic device rather than one that diagnoses conditions.
No
The device description explicitly states it is a "Blue Light Therapy System" and is identical to a previously cleared system (K072767). This strongly implies a hardware component that emits blue light for therapeutic purposes, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide phototherapeutic light to the body to treat dermatological conditions, specifically mild to moderate inflammatory acne vulgaris. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a light therapy system. IVD devices are typically used to examine specimens (like blood, urine, or tissue) outside of the body to diagnose diseases or conditions.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, the "Quasar Blue" Blue Light Therapy System is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OLP
Device Description
The Quasar Blue Light Therapy System has similar physical and technical characteristics to the predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home use (Over the Counter)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All necessary testing has been performed for the Quasar Blue Light Therapy System to assure substantial equivalence to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 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 |
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:
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.
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
1
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.
:
.
2
Silver Bay LLC Quasar Blue Light Therapy system
Premarket Notification
3
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
4
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
5
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:
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.
(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 X (Optional Format 1-2-96)
Mark M. Mulhern
ivision Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
Silver Bay LLC Quasar Blue Light Therapy system
510(k) Number
Premarket Notification
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