(163 days)
Not Found
No
The device description focuses solely on the physical components and light emission technology (LEDs). There is no mention of any software, algorithms, data processing, or learning capabilities that would indicate the presence of AI or ML. The performance study is a human factors study, not a study evaluating algorithmic performance.
Yes
The device is intended to emit energy for the treatment of full-face wrinkles, which is a therapeutic indication. The description also mentions the device is "used for applying therapy."
No
This device is intended for treatment (wrinkle reduction) by emitting light, not for diagnosing any condition.
No
The device description explicitly states it consists of hardware components including LEDs, a hand-held device body, an on/off switch, and a power supply. It is a physical device that emits light energy.
Based on the provided text, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that these devices emit light energy directly onto the skin for the treatment of wrinkles. They do not involve the analysis of any biological samples (like blood, urine, tissue, etc.).
- The intended use is therapeutic. The devices are indicated for the "treatment of full-face wrinkles," which is a therapeutic application, not a diagnostic one.
- The device description focuses on light emission and physical characteristics. The description details the type of light emitted, the physical design of the device, and the power source. It does not mention any components or processes related to analyzing biological specimens.
Therefore, these devices fall under the category of therapeutic devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Quasar C100 is an Over-The-Counter handheld device intended to emit energy in the red/IR spectrum, specifically indicated for use in the treatment of full-face wrinkles.
The Baby Quasar Plus is an Over-The-Counter handheld device intended to emit energy in the red/IR spectrum, specifically indicated for use in the treatment of full-face wrinkles.
The Quasar MD Plus is an Over-The-Counter handheld device intended to emit energy in the red/IR spectrum, specifically indicated for use in the treatment of full-face wrinkles
Product codes (comma separated list FDA assigned to the subject device)
OHS
Device Description
The Silver Bay, Quasar C100. Anti-Wrinkle device consists of a collection of red and near infrared diodes (LEDs), packaged in a compact hand held device. The device has a head size of 20 cm² containing the LED array and an on/off switch.
The device is made of ABS plastic with clear polycarbonate lenses covering the LED light source. The Quasar C100 uses a 12 volt wall mount power supply.
The C100 light delivery system used for applying therapy for the treatment of full-face wrinkles, by emitting at least 65 mWcm² of red and near infrared (610nm to 850nm) light via an electric light emitting diodes [LEDs] energy source. There are 20 red LEDs and 20 infrared LEDs in the head. The device is not intended for ocular applications or direct eye exposure.
The Silver Bay, Baby Quasar Plus Anti-Wrinkle device consists of a collection of red and near infrared diodes (LEDs), packaged in a compact hand held device. The device has a head size of 8.7 cm 2 containing the LED array and an on/off switch.
The device is made of anodized aluminum.
The Baby Quasar Plus uses a 12 volt wall mount power supply.
The Baby Quasar Plus light delivery system used for applying therapy for the use in the treatment of full-face wrinkles, by emitting at least 65 mWcm² of red and near infrared (610nm to 850nm) light via an electric light emitting diodes [LEDs] energy source. There are 12 red LEDs and 12 infrared LEDs in the head. The device is not intended for ocular applications or direct eye exposure.
The Silver Bay, Quasar MD Plus Anti-Wrinkle device consists of a collection of red and near infrared diodes (LEDs), packaged in a compact hand held device. The device has a head size of 15.2 cm 2 containing the LED array and an on/off switch.
The device is made of anodized aluminum.
The Baby Quasar Plus uses a 12 volt wall mount power supply.
The Quasar MD Plus light delivery system used for applying therapy for the use in the treatment of full-face wrinkles, by emitting at least 65 mWcm² of red and near infrared (610nm to 850m), light via an electric light emitting diodes [LEDs] energy source. There are 12 red LEDs and 12 infrared LEDs in the head. The device is not intended for ocular applications or direct eve exposure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
full-face
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)
Performance Testing and Standards:
These devices have 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.
The device has been tested and is in conformity with IEC/EN 60601-1, IEC/ EN 60601-1-2, IEC 62471 Standards.
A Human Factors Study for label comprehension and device use was conducted. The results of the HF Study found that the C100, Baby Quasar + and Quasar MD + have been found to be adequately safe and effective for the intended users, its intended uses, and use environments.
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
510(k) Summary
K130225
This summary of 510(k) summary information is being submitted in accordance with the requirements of 21 CFR § 878.4810.
Submission Date: January 15, 2013
| 1. Submitter Information: | AEGIS Regulatory, Inc. - Robert T. Wagner |
|---|---|
| 2424 Dempster Drive | |
| Coralville, IA 52241 | |
| Tel.: 865-982-5552 | |
| Email: bob@fdalistingconsultants.com | |
| For Manufacturer: | Silver Bay, LLC d/b/a Quasar Bio-Technologies |
| Attn: Peter Nesbitt | |
| 1431 Tallevast Rd. | |
| Sarasota, FL 34231 | |
| Tel.: 941-306-5812 | |
| Email: peter@quasarbiotech.com |
2. General Information
- 2.1
2.2 Common/Usual Name: Light Therapy System, Quasar C100, Baby Quasar Plus, Quasar
MD Plus
2.3 Proprietary Names: Quasar Calypso C100 Wrinkle Reduction Device, Baby Quasar Plus,
Quasar MD Plus
- 2.4 Classification: Class II
- 2.5 Classification Number: 878.4810
- 2.6 Product Codes: OHS
1
3. Device Description:
The Silver Bay, Quasar C100. Anti-Wrinkle device consists of a collection of red and near infrared diodes (LEDs), packaged in a compact hand held device. The device has a head size of 20 cm² containing the LED array and an on/off switch.
The device is made of ABS plastic with clear polycarbonate lenses covering the LED light source. The Quasar C100 uses a 12 volt wall mount power supply.
The C100 light delivery system used for applying therapy for the treatment of full-face wrinkles, by emitting at least 65 mWcm² of red and near infrared (610nm to 850nm) light via an electric light emitting diodes [LEDs] energy source. There are 20 red LEDs and 20 infrared LEDs in the head. The device is not intended for ocular applications or direct eye exposure.
The Silver Bay, Baby Quasar Plus Anti-Wrinkle device consists of a collection of red and near infrared diodes (LEDs), packaged in a compact hand held device. The device has a head size of 8.7 cm 2 containing the LED array and an on/off switch.
The device is made of anodized aluminum.
The Baby Quasar Plus uses a 12 volt wall mount power supply.
The Baby Quasar Plus light delivery system used for applying therapy for the use in the treatment of full-face wrinkles, by emitting at least 65 mWcm² of red and near infrared (610nm to 850nm) light via an electric light emitting diodes [LEDs] energy source. There are 12 red LEDs and 12 infrared LEDs in the head. The device is not intended for ocular applications or direct eye exposure.
The Silver Bay, Quasar MD Plus Anti-Wrinkle device consists of a collection of red and near infrared diodes (LEDs), packaged in a compact hand held device. The device has a head size of 15.2 cm 2 containing the LED array and an on/off switch.
The device is made of anodized aluminum.
The Baby Quasar Plus uses a 12 volt wall mount power supply.
The Quasar MD Plus light delivery system used for applying therapy for the use in the treatment of full-face wrinkles, by emitting at least 65 mWcm² of red and near infrared (610nm to 850m), light via an electric light emitting diodes [LEDs] energy source. There are 12 red LEDs and 12 infrared LEDs in the head. The device is not intended for ocular applications or direct eve exposure.
4. Indications / Intended Use:
The Quasar C100 is an Over-The-Counter handheld device intended to emit energy in the red/IR spectrum, specifically indicated for use in the treatment of full-face wrinkles.
The Baby Quasar Plus is an Over-The-Counter handheld device intended to emit energy in the red/IR spectrum, specifically indicated for use in the treatment of full-face wrinkles.
The Quasar MD Plus is an Over-The-Counter handheld device intended to emit energy in the red/IR spectrum, specifically indicated for use in the treatment of full-face wrinkles
2
Rx or OTC:
he C100, Baby Quasar Plus, and Quasar MD Plus are Over the Counter . The labeling, instructions, and
Predicate Device ખં
This device is substantially equivalent to the following predicate devices, which are currently in safe and effective commerce
- K120775 Light for Wrinkles (Led Intellectual Properties, LLC : し
- K112362 Quasar C100 Anti-Wrinkle Device (Quasar Bio-Tech Inc ਪ
Predicate Cha
| Device | |||||
|---|---|---|---|---|---|
| Light for Wrinkles | |||||
| AAL OCT (K120775) | |||||
| LED Intellectual | |||||
| Properties LLC | C100 | ||||
| Quasar Bio-Tech Inc | |||||
| K112362 | |||||
| A Predicate Device | C100 | ||||
| Quasar Bio-Tech Inc | |||||
| KXXXXXX | |||||
| This Submission | Baby Quasar Plus | ||||
| Quasar Bio-Tech Inc | |||||
| KXXXXXX | |||||
| This Submission | Quasar MD Plus | ||||
| Quasar Bio-Tech Inc | |||||
| KXXXXXX | |||||
| This Submission | |||||
| Indications | The Light for Wrinkles is | ||||
| an Over-The-Counter | |||||
| handheld device | |||||
| intended for use in the | |||||
| treatment of full-face | |||||
| wrinkles. The target | |||||
| patient population for | |||||
| the AAL OCT is persons | |||||
| with facial wrinkles. It | |||||
| is designed for home | |||||
| use. | The C100 is intended to | ||||
| emit energy in the red | |||||
| and IR region of the | |||||
| spectrum, specifically | |||||
| indicated for use in the | |||||
| treatment of periorbital | |||||
| wrinkles. The target | |||||
| patient population for the | |||||
| C100 is periorbital | |||||
| wrinkles. The C100 is | |||||
| designed for home use. | The C100 is intended to | ||||
| emit energy in the red | |||||
| and IR region of the | |||||
| spectrum, specifically | |||||
| indicated for use in the | |||||
| treatment of full-face | |||||
| wrinkles. The target | The Baby Quasar Plus is | ||||
| intended to emit energy in | |||||
| the red and IR region of | |||||
| the spectrum, specifically | |||||
| indicated for use in the | |||||
| treatment of full-face | |||||
| wrinkles. The target | |||||
| patient population for the | |||||
| Baby Quasar Plus is the | |||||
| same as the predicate | |||||
| devices. Like the | |||||
| predicate devices, the | |||||
| Baby Quasar Plus is | |||||
| designed for home use. | The Quasar MD Plus is | ||||
| intended to emit energy in | |||||
| the red and IR region of | |||||
| the spectrum, specifically | |||||
| indicated for use in the | |||||
| treatment of full-face | |||||
| wrinkles. The target | |||||
| patient population for the | |||||
| Quasar MD Plus is the | |||||
| same as the predicate | |||||
| devices. Like the predicate | |||||
| devices, the Quasar MD | |||||
| Plus is designed for home | |||||
| use. |
3
| Device | Light for Wrinkles
AAL OCT (K120775)
LED Intellectual
Properties LLC | C100
Quasar Bio-Tech Inc | C100
Quasar Bio-Tech Inc | Baby Quasar Plus
Quasar Bio-Tech Inc | Quasar MD Plus
Quasar Bio-Tech Inc |
|-----------------------|-------------------------------------------------------------------------------|------------------------------------------------|------------------------------------------------|------------------------------------------------|------------------------------------------------|
| | A Predicate Device | K112362 | KXXXXXX | KXXXXXX | KXXXXXX |
| | A Predicate Device | A Predicate Device | This Submission | This Submission | This Submission |
| Handheld | Yes | Yes | Yes | Yes | Yes |
| Wavelengths | 605nm, 630nm, 660nm,
855nm | 610, 630 and 660, 850nm | 610, 630 and 660, 850nm | 610, 630 and 660, 850nm | 610, 630 and 660, 850nm |
| Modes | On/Off | On/Off | On/Off | On/Off | On/Off |
| IR power
source | LEDs | LEDs | LEDs | LEDs | LEDs |
| Visible light
LEDs | Yes | Yes | Yes | Yes | Yes |
| Waveform | Constant | Constant | Constant | Constant | Constant |
| Energy Source | 70 LEDs over 27 sq. cm. | 40 LEDs. Over 20 sq. cm | 40 LEDs. Over 20 sq. cm | 24 LEDs. Over 8.7 sq. cm | 24 LEDs. Over 15.2 sq. cm |
| Energy Level | 65 mW total | 65 mW total | 65 mW total | 65 mW total | 65 mW total |
| Power Supply | 115VAC Electric Outlet
Power Supply | 115VAC Electric Outlet
Power Supply | 115VAC Electric Outlet
Power Supply | 115VAC Electric Outlet
Power Supply | 115VAC Electric Outlet
Power Supply |
| Treatment
Time | 3 minutes daily,
minimum 5 days per
week | 3 minutes daily,
minimum 5 days per
week | 3 minutes daily,
minimum 5 days per
week | 3 minutes daily,
minimum 5 days per
week | 3 minutes daily,
minimum 5 days per
week |
| Target
Population | Individuals with facial
lines and wrinkles. | Individuals with
periorbital lines and | Individuals with facial
lines and wrinkles. | Individuals with facial
lines and wrinkles. | Individuals with facial
lines and wrinkles. |
,
"
4
| Device | Location for Use | |||||
|---|---|---|---|---|---|---|
| Light for Wrinkles | AAL OCT (K120775) | |||||
| LED Intellectual | ||||||
| Properties LLC | A Predicate Device | wrinkles. | OTC | |||
| C100 | Quasar Bio-Tech Inc | K112362 | A Predicate Device | OTC | ||
| C100 | Quasar Bio-Tech Inc | KXXXXXX | This Submission | OTC | ||
| Baby Quasar Plus | Quasar Bio-Tech Inc | KXXXXXX | This Submission | OTC | ||
| Quasar MD Plus | Quasar Bio-Tech Inc | KXXXXXX | This Submission | OTC |
mmary of the technological characteristics of the device compared to predicate dev
are abovent grouped
5
6. Biocompatibility:
The only patient contact material in the C100 is the light head and body of the device.
The light head in contact with the face is Polycarbonate and the body is constructed of ABS plastic, the same materials used in the predicate device. The biocompatibility of these materials are well known and considered safe when in contact with healthy skin. A review of the Biocompatibility decision is shown on the "General Program Memorandum- #G95-1, Attachment C, Biocompatibility Flow Chart for the Selection of Toxicity Tests for 510(k)s."
The conclusion is that the C100 m does not raise any new safety issues.
7. Performance Testing and Standards:
These devices have 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.
The device has been tested and is in conformity with IEC/EN 60601-1, IEC/ EN 60601-1-2, IEC 62471 Standards.
A Human Factors Study for label comprehension and device use was conducted. The results of the HF Study found that the C100, Baby Quasar + and Quasar MD + have been found to be adequately safe and effective for the intended users, its intended uses, and use environments.
8. Statement of Safety and Effectiveness:
The information in this 510(k) submission was used to support the safety and effectiveness of this device with respect to its cited predicates.
9. Substantial Equivalence Discussion
After an analysis of the safety, indications, intended uses, dose rates, 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 listed in Section 5 Therefore substantial equivalency is requested.
6
Image /page/6/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract symbol on the right, consisting of three curved lines that resemble a person with outstretched arms. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all caps and is smaller than the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Silverbay LLC, d/b/a Quasar Biotech % AEGIS Regulatory, Inc. Ms. Susan Anthoney 2424 Dempster Drive Coralville, Iowa 52241
July 11, 2013
Re: K130225
Trade/Device Name: Quasar C100, Baby Quasar Plus, Quasar MD Plus; Wrinkle Reduction Device 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: OHS Dated: June 11, 2013 Received: June 18, 2013
Dear Ms. Anthoney:
We have reviewed vour 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. Iisting 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 or any Federal statutes and regulations administered by other Federal agencies. You must
7
Page 2 - Ms. Susan Anthoney
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/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/Safetv/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 yours.
Mark N. Melkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
INDICATIONS FOR USE STATEMENT
510(k) Number: K130225
Device Name: Quasar C100, Baby Quasar Plus, Quasar MD Plus; Wrinkle Reduction Device
Indications for Use:
The Quasar C100 Wrinkle Reduction Device is intended to emit energy in the red and IR region of the spectrum, specifically indicated for the treatment of full-face wrinkles.
The Baby Quasar Plus Wrinkle Reduction Device is intended to emit energy in the red and iR region of the spectrum, specifically indicated for the treatment of fullface wrinkles.
The Quasar MD Plus Wrinkle Reduction Device is intended to emit energy in the red and IR region of the spectrum, specifically indicated for the treatment of fullface wrinkles.
(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)
زنرین Neil R Ogden 2013.07.11 09:24:16 -04'00'
(Division Sign-Off) for MXM
Division of Surgical Devices
510(k) Number _K130225
Silver Bay LLC
.