(91 days)
Not Found
No
The device description and performance studies focus on light therapy and basic safety features (skin sensor). There is no mention of AI, ML, or any complex data processing or decision-making capabilities.
Yes
The device is intended for "treatment of mild to moderate acne vulgaris," which indicates a therapeutic purpose.
No
The document states that the devices are "intended to emit energy in the light spectrum for use in the treatment of mild to moderate acne vulgaris." This describes a therapeutic function, not a diagnostic one. There is no mention of the device being used to identify, measure, or analyze a condition.
No
The device description explicitly lists multiple hardware components, including a handheld unit, LED module, battery, power supply, and goggles. It is a physical device that emits light for treatment.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of mild to moderate acne vulgaris by emitting light energy. IVD devices are used to diagnose diseases or conditions by examining specimens from the human body (like blood, urine, tissue).
- Device Description: The description details a handheld device that emits light and has features like a cleansing brush. There is no mention of collecting or analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Providing diagnostic information.
- Using reagents or assays.
The device is clearly described as an Over the Counter (OTC) device for therapeutic use (treating acne) through light therapy.
N/A
Intended Use / Indications for Use
The Sonilase Blue is a hand held OTC device intended to emit energy in the light spectrum for use in the treatment of mild to moderate acne vulgaris.
The Sonilase Blue- UV Clean is a hand held OTC device intended to emit energy in the light spectrum for use in the treatment of mild to moderate acne vulgaris.
The Sonilase Blue-UV Clean Plus is a hand held OTC device intended to emit energy in the blue region of the light spectrum for use in the treatment of mild to moderate acne vulgaris.
Product codes (comma separated list FDA assigned to the subject device)
OLP
Device Description
The Sonilase Blue, Sonilase Blue-Clean, and Sonilase Blue-UV Clean Plus are modular system devices that offer blue light therapy for the treatment of mild to moderate acne vulgaris.
The Sonilase Blue device components include the handheld unit containing the LED module with 3 (415nm) LEDs. attachable clear plastic lens cover. an adjunct attachable cleansing brush head, recharging stand, 7.4 v LI-ION BATTERY, 9V UL approved power supply and goggles.
The Sonilase Blue-Clean device components include the handheld unit containing the LED module with 3 blue LEDs (415nm) attachable opaque lens cover, an adjunct attachable cleansing brush head. recharging stand. 7.4 v LI-ION BATTERY. 9V UL approved power supply and goggles.
The Sonilase Blue-UV Clean Plus device components include the handheld unit containing the LED module with 3 blue LEDs (415nm) and 3 UV sanitizing LEDs , attachable opaque lens cover, a detachable cleansing brush head, recharging stand, 7.4 v LI-ION BATTERY, 9V UL approved power supply and goggles.
The Sonilase Blue, Sonilase Blue-UV Clean, and Sonilase Blue-UV Clean Plus devices operate by a cordless system drawing upon their 7.4V rechargeable LI-ION battery to deliver the treatment.
The Sonilase Blue. Sonilase Blue-Clean, and Sonilase Blue-UV Clean Plus utilize blue light at 415 nm +/- 5nm.
The Sonilase Blue is applied directly to the skin to ensure consistent administration of light during each treatment.
The Sonilase Blue-Clean and Sonilase Blue-UV Clean Plus are applied to the skin with the cleansing brush still attached, but the amount of treatment energy (Dose) delivered to the skin is the same.
The Sonilase Blue, Sonilase Blue- Clean, and Sonilase Blue-UV Clean Plus have a skin sensor that will not allow the device to illuminate unless it is in contact with the skin as a safety feature.
The Sonilase Blue, Sonilase Blue- Clean, and Sonilase Blue-UV Clean Plus devices do not contain any user serviceable components. The devices are sold as Over the Counter (OTC).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Usability/Label Comprehension Study: 39 participants.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing and Standards:
Testing of the Sonilase Blue series of devices included functional performance testing, software validation testing and user safety testing.
The results of this testing are as follows:
Conforms to international consensus standards:
ELECTRICAL SAFETY: Recognition Number 19-4: IEC/EN 60601-1:2005 Edition 3/(R)2012 And A1:2012 Medical Electrical Equipment Part 1: General Requirements For Basic Safety And Essential Performance (lec 60601-1:2005, Mod). (General II (ES/EMC))
PERFORMANCE: Recognition Number 12-242: IEC 60601-2-57 Edition 1.0 2011-01, Medical Electrical Equipment -- Part 2-57: Particular Requirements For The Basic Safety And Essential Performance Of Non-Laser Light Source Equipment Intended for Therapeutic Diagnostic Monitoring and Cosmetic/Aesthetic Use (Radiology)
EMC: Recognition Number 19-1: IEC 60601-1-2 Edition 3: 2007-03, Medical Electrical Equipment Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests. (General II (ES/EMC))
The Sonilase Blue series of device's software was tested and validated in accordance with FDA's "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices,"
A Usability/Label Comprehension Study was conducted with 39 participants.
The results of the study found that:
100% of the participants were able to comprehend the labeling.
97% of the participants were able to use the device successfully.
User Safety testing reflects device can be used in a safe and effective manner.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center of the logo is an abstract symbol of a human figure, represented by three overlapping profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 30, 2015
Biorenew Labs, LLC c/o Susan Anthoney-Dewet Aegis Regulatory, Inc. 2424 Dempster Drive Coralville, IA 52241
Re: K152889
Trade/Device Name: Sonilase Blue Blue, Sonilase Blue-Clean, Sonilase UV-Clean Plus 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: September 29, 2015 Received: September 30, 2015
Dear Ms. Anthoney-Dewet:
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 or any Federal statutes and regulations administered by other Federal agencies. You must
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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.
David Krause -S
- for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152889
Device Name
Sonilase Blue, Sonilase Blue-UV Clean, and Sonilase Blue-UV Clean Plus
Indications for Use (Describe)
The Sonilase Blue is a hand held OTC device intended to emit energy in the light spectrum for use in the treatment of mild to moderate acne vulgaris.
The Sonilase Blue-UV Clean is a hand held OTC device intended to emit energy in the light spectrum for use in the treatment of mild to moderate acne vulgaris.
The Sonilase Blue-UV Clean Plus is a hand held OTC device intended to emit energy in the blue region of the light spectrum for use in the treatment of mild to moderate acne vulgaris.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CER 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CER 801 Subpart C) | X |
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3
510(k) Summary
K152889
This summary of 510(k) summary information is being submitted in accordance with the requirements of 21 CFR § 878.4810.
Submission Date: September 16, 2015
1. Submitter Information: AEGIS Regulatory, Inc. - Susan Anthoney-DeWet 2424 Dempster Drive Coralville, IA 52241 Tel.: 865-982-5552
Email: sue@fdalistingconsultants.com
For Specifications Developer: Biorenew Labs, LLC
Attn: Jon David 415 Pier Avenue Hermosa Beach, CA 90254 Tel.: 310-400-0631 Email: jon@biorenewlabs.com
2. General Information
- 2.1 Classification Name: Light Based Over-The-Counter Powered Light Based Laser For Acne
2.2 Common/Usual Name: Sonilase Blue, Sonilase Blue-Clean, and Sonilase UV-Clean Plus
Light Devices
-
2.3 Proprietary Names: Sonilase Blue, Sonilase Blue- Clean, and Sonilase UV-Clean Plus Light
Devices -
2.4 Classification: Class II
-
2.5 Classification Number: 878.4810
-
2.6 Product Code: OLP
-
- Device Description:
4
The Sonilase Blue, Sonilase Blue-Clean, and Sonilase Blue-UV Clean Plus are modular system devices that offer blue light therapy for the treatment of mild to moderate acne vulgaris.
The Sonilase Blue device components include the handheld unit containing the LED module with 3 (415nm) LEDs . attachable clear plastic lens cover. an adjunct attachable cleansing brush head, recharging stand, 7.4 v LI-ION BATTERY, 9V UL approved power supply and goggles.
The Sonilase Blue-Clean device components include the handheld unit containing the LED module with 3 blue LEDs (415nm) attachable opaque lens cover, an adjunct attachable cleansing brush head. recharging stand. 7.4 v LI-ION BATTERY. 9V UL approved power supply and goggles.
The Sonilase Blue-UV Clean Plus device components include the handheld unit containing the LED module with 3 blue LEDs (415nm) and 3 UV sanitizing LEDs , attachable opaque lens cover, a detachable cleansing brush head, recharging stand, 7.4 v LI-ION BATTERY, 9V UL approved power supply and goggles.
The Sonilase Blue, Sonilase Blue-UV Clean, and Sonilase Blue-UV Clean Plus devices operate by a cordless system drawing upon their 7.4V rechargeable LI-ION battery to deliver the treatment.
The Sonilase Blue. Sonilase Blue-Clean, and Sonilase Blue-UV Clean Plus utilize blue light at 415 nm +/- 5nm.
The Sonilase Blue is applied directly to the skin to ensure consistent administration of light during each treatment.
The Sonilase Blue-Clean and Sonilase Blue-UV Clean Plus are applied to the skin with the cleansing brush still attached, but the amount of treatment energy (Dose) delivered to the skin is the same.
The Sonilase Blue, Sonilase Blue-Clean, and Sonilase Blue-UV Clean Plus have a skin sensor that will not allow the device to illuminate unless it is in contact with the skin as a safety feature.
The Sonilase Blue, Sonilase Blue- Clean, and Sonilase Blue-UV Clean Plus devices do not contain any user serviceable components. The devices are sold as Over the Counter (OTC).
5
4. Indications / Intended Use:
The Sonilase Blue is a hand held OTC device intended to emit energy in the light spectrum for use in the treatment of mild to moderate acne vulgaris.
The Sonilase Blue- Clean is a hand held OTC device intended to emit energy in the light spectrum for use in the treatment of mild to moderate acne vulgaris.
The Sonilase Blue-UV Clean Plus is a hand held OTC device intended to emit energy in the light spectrum for use in the treatment of mild to moderate acne vulgaris.
Rx or OTC:
The Sonilase Blue series of light device are Over the Counter (OTC) devices. The labeling, instructions, and User Operations (21 CFR § 801.60 and 61), are designed for layman understanding and use. The predicate device is OTC.
5. Predicate Device:
These devices are substantially equivalent to the following predicate devices, which are currently in safe and effective commerce:
Primary Predicate Device: K121435 - Silk'n Blue (Home Skinovations LTD)
Secondary Predicate Device: K124042 – Tanda Mini Skincare System (Syneron Beauty Inc.)
Predicate Chart
| Device | Silk 'N Blue | Tanda Mini Skincare
System | Sonilase Blue-Acne | Sonilase Blue-Clean | Sonilase Blue-UV Clean
Plus |
|--------|---------------------------|-------------------------------|----------------------------|----------------------------|--------------------------------|
| | Home Skinovations
LTD. | Syneron Beauty Inc. | Model-SL113B | Model-SL113BC | Model-SL113BUV+ |
| | K121435 | K124042 | Biorenew Labs, LLC | Biorenew Labs, LLC | Biorenew Labs, LLC |
| | A Predicate Device | A Predicate Device | K152889
This Submission | K152889
This Submission | K152889
This Submission |
6
| Device | Silk 'N Blue | Tanda Mini Skincare
System | Sonilase Blue-Acne | Sonilase Blue-Clean | Sonilase Blue-UV Clean
Plus |
|-----------------------|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Home Skinovations
LTD. | Syneron Beauty Inc. | Model-SL113B | Model-SL113BC | Model-SL113BUV+ |
| | K121435 | K124042 | Biorenew Labs, LLC | Biorenew Labs, LLC | Biorenew Labs, LLC |
| | A Predicate Device | A Predicate Device | K152889 | K152889 | K152889 |
| | | | This Submission | This Submission | This Submission |
| Indications | | The Tanda Mini Skincare
System is generally
indicated to treat
dermatological
conditions. Specifically,
blue light modules are
indicated to treat mild to
moderate inflammatory
acne. | The Sonilase Blue is a
hand held OTC device
intended to emit energy
in the blue region of the
light spectrum for use in
the treatment of mild to
moderate acne vulgaris.. | The Sonilase Blue-Clean
is a hand held OTC device
intended to emit energy
in the blue region of the
light spectrum for use in
the treatment of mild to
moderate acne vulgaris | The Sonilase Blue-UV
Clean Plus is a hand held
OTC device intended to
emit energy in the blue
region of the light
spectrum for use in the
treatment of mild to
moderate acne vulgaris |
| Handheld | Yes | Yes | Yes | Yes | Yes |
| Wavelength | 415 nm +/- 15nm | 414 nm +/- 6nm | 415 nm +/- 5nm | 415 nm +/5nm | 415 nm +/5nm |
| Modes | On/Off | On/Off | On/Off | On/Off | On/Off |
| Blue power
source | LEDs | LEDs | LEDs | LEDs | LEDs |
| Energy Source | 24 LEDs . Over 7 cm2 | 7 LEDs. Unknown area. | 3 LEDs. Over 9.6 cm2 | 3 LEDs. Over 9.6 cm2 | 3 LEDs. Over 9.6 cm2 |
| Energy Level | 50 mW/cm2 | 22.4 mW/cm2 | 50 mW/cm2 | 50 mW/cm2 | 50 mW/cm2 |
| Method of
Delivery | Blue light treatment
administered through
stainless steel treatment
head containing LED | Blue light treatment
administered through
treatment head. | Blue light treatment
administered through
treatment head. | Blue light treatment
administered through
lens or brush. | Blue light treatment
administered through
lens or brush. |
| Device | Silk 'N Blue
Home Skinovations LTD.
K121435
A Predicate Device | Tanda Mini Skincare System
Syneron Beauty Inc.
K124042
A Predicate Device | Sonilase Blue-Acne
Model-SL113B
Biorenew Labs, LLC
K152889
This Submission | Sonilase Blue-Clean
Model-SL113BC
Biorenew Labs, LLC
K152889
This Submission | Sonilase Blue-UV Clean Plus
Model-SL113BUV+
Biorenew Labs, LLC
K152889
This Submission |
| | array. | | | | |
| Power Supply | Unknown | One 9v rechargeable alkaline battery | One 7.4v rechargeable LI-ION BATTERY | One 7.4v rechargeable LI-ION BATTERY | One 7.4v rechargeable LI-ION BATTERY |
| Treatment
Time | * 3-4 minutes daily, for 3-7 weeks | *2 minutes, 3 times per day. | 4 minutes per area, daily. | 4 minutes per area, daily. | 4 minutes per area, daily. |
| Target
Population | Individuals with mild to moderate acne | Individuals with mild to moderate acne | Individuals with mild to moderate acne | Individuals with mild to moderate acne | Individuals with mild to moderate acne |
| Location for
Use | OTC | OTC | OTC | OTC | OTC |
7
Summary of the technological characteristics of the device compared to predicate device:
-
Has the same intended use as the predicate (i.e., Treatment of mild to moderate acne vulgaris;
-
Has the same output (i.e., 50 mW/cm2 ) as the predicate;
-
Utilizes the same wavelength (i.e., 415 nm) as the predicate device;
-
Utilizes the same standard dose (i.e., 12J/cm2) as the predicate device;
8
The Sonilase Blue Light Devices and the above referenced predicate devices are Over the Counter Devices used to treat mild to moderate acne vulgaris as defined in 21 CFR § 878.4810. These devices at 415nm to provide narrow bands of light energy to treat acne vulgaris. The performance achieved by these devices is similar with equal power output. The devices are handheld, and intended to be placed directly on the skin. They are manufactured out of similar materials. Based upon comparison to the predicate device, the Sonilase Blue the same intended uses, with similar technological characteristics as the predicate device. The system performs as intended and does not raise any new safety or effectiveness issues.
6. Technological Characteristics
The Sonilase Blue light delivery system used for applying therapy for the treatment of acne vulgaris, by emitting at least 50 mW/cm² of blue (415 nm +/- 5nm) light via an electic light emitting diodes [LEDs] energy source. There are 3 blue LEDs in the head. The LED head size is 9.6cm².
The Sonilase Blue- Clean light delivery system used for applying the treatment of acne vulgaris, by emitting at least 50 mW/cm² of blue (415 nm +/- 5nm) light via an electric light emitting diodes [LEDs] energy source, transmitted through the cleansing brush head. There are 3 blue LEDs in the head. The LED head size is 9.6cm².
The Sonilase Blue-UV Clean Plus light delivery system used for the treatment of acne vulgaris, by emitting at least 50 mW/cm² of blue (415 nm +/- 5nm) light via an electric light emitting diodes [LEDs] energy source, transmitted through the cleansing brush head. There are 3 blue LEDs in the head. The LED head size is 9.6cm².
The Sonilase Blue, Sonilase Blue-UV Clean Plus devices are not intended for ocular applications or direct eve exposure.
7. Performance Testing and Standards:
Testing of the Sonilase Blue series of devices included functional performance testing, software validation testing and user safety testing.
The results of this testing are as follows:
Conforms to international consensus standards:
9
ELECTRICAL SAFETY:
Recognition Number 19-4:
- IEC/EN 60601-1:2005 Edition 3/(R)2012 And A1:2012 Medical Electrical Equipment Part 1: General Requirements For Basic Safety And Essential Performance (lec 60601-1:2005, Mod). (General II (ES/EMC))
PERFORMANCE:
Recognition Number 12-242:
- · IEC 60601-2-57 Edition 1.0 2011-01, Medical Electrical Equipment -- Part 2-57: Particular Requirements For The Basic Safety And Essential Performance Of Non-Laser Light Source Equipment Intended for Therapeutic Diagnostic Monitoring and Cosmetic/Aesthetic Use (Radiology)
EMC:
Recognition Number 19-1:
- IEC 60601-1-2 Edition 3: 2007-03, Medical Electrical Equipment Part 1-2: General Requirements For Basic Safety And . Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests. (General II (ES/EMC))
The Sonilase Blue series of device's software was tested and validated in accordance with FDA's "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices,"
A Usability/Label Comprehension Study was conducted with 39 participants.
The results of the study found that:
100% of the participants were able to comprehend the labeling.
97% of the participants were able to use the device successfully.
User Safety testing reflects device can be used in a safe and effective manner.
9. Substantial Equivalence Conclusion
After an analysis of the safety, intended uses, performance, design materials, power output, technological
properties, treatment areas, and treatment regimes the manufacturer believes that no significant differences exist between the
device and the predicate device. Therefore substantial equivalency is requested.