(115 days)
Not Found
No
The device description and performance studies focus on light therapy and electrical safety, with no mention of AI, ML, or data processing that would indicate such technology.
Yes
The device is indicated for the treatment of inflammatory acne, which is a medical condition.
No
The device description and intended use clearly state that the Clear Bi-Light is indicated for the treatment of acne, not for its diagnosis. Diagnostic devices are used to identify or detect a disease, while this device uses light therapy to manage a condition.
No
The device description explicitly lists hardware components such as a handpiece, treatment heads, charger stand, AC adaptor, and goggles. The performance studies also include testing for electrical safety and electromagnetic compatibility, which are relevant to hardware.
Based on the provided information, the Clear Bi-Light is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "treatment of mild to moderate inflammatory acne." This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a "hand-held, light emitting device for treating mild to moderate acne." It uses light to treat a condition, not to analyze biological samples for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Clear Bi-Light's function is to directly treat a condition using light therapy.
N/A
Intended Use / Indications for Use
The Clear Bi-Light is indicated for the treatment of mild to moderate inflammatory acne.
Product codes
OLP
Device Description
The Clear Bi-Light is a hand-held, light emitting device for treating mild to moderate acne. The Clear Bi-Light is non-prescription and is intended for over-the-counter sale. Each Clear Bi-Light package includes the following:
- One Clear Bi-Light rechargeable handpiece
- Two Treatment Heads
- One blue light (405 - 420 nm)
- One red light (630 660 nm)
- One Charger Stand
- One AC adaptor power cord
- One pair goggles
- The Clear Bi-Light Instruction Manual
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
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing right, stacked on top of each other, with flowing lines connecting them.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 15, 2016
Michael Todd, LP % Sheila Hemeon-Heyer, JD, RAC Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst, Massachusetts 01002
Re: K153081 Trade/Device Name: Clear Bi-light 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: January 20, 2016 Received: January 20, 2016
Dear Sheila Hemeon-Heyer:
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 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 of medical device
1
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Jennifer R. Stevenson -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) K153081
Device Name Clear Bi-Light
Indications for Use (Describe)
The Clear Bi-Light is indicated for the treatment of mild to moderate inflammatory acne.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
| A. | Submitter: | Heyer Regulatory Solutions, LLC
P.O. Box 2151
Amherst, MA 01004-2151 |
|----|------------|----------------------------------------------------------------------------|
| | Contact: | Sheila Hemeon-Heyer
Sheila@heyer-regulatory.com |
Device Manufacturer / 510(k) Applicant B.
| Michael Todd, LP | |
|---|---|
| 648 Port St Lucie Blvd | |
| Port St Lucie, FL 34953 | |
| Contact: | Lilia Friend |
| Senior Vice President | |
| Tel: | (772) 343-0222 |
| Email: | lil@michaeltoddusa.com |
C. Date Prepared: October 23, 2015
Device Name and Classification Information: D.
| Trade Name: | Clear Bi-Light |
|---|---|
| Common/usual Name: | Light Emitting Diode Therapy System |
| Classification Name: | Over-the-Counter Powered Light Based Laser for |
| Acne | |
| Product Code, CFR: | OLP, 21 CFR 878.4810 |
| Review Panel: | General and Plastic Surgery Devices |
| Class: | II |
- E. Predicate Device: Tanda Mini Skincare System, K124042 Silkn Blue, K121435 OmniLux Clear U, K081307
4
Device Description: ட்
The Clear Bi-Light is a hand-held, light emitting device for treating mild to moderate acne. The Clear Bi-Light is non-prescription and is intended for over-the-counter sale. Each Clear Bi-Light package includes the following:
- One Clear Bi-Light rechargeable handpiece ●
- Two Treatment Heads o
- O One blue light (405 - 420 nm)
- One red light (630 660 nm) o
- One Charger Stand ●
- One AC adaptor power cord ●
- One pair goggles
- The Clear Bi-Light Instruction Manual
Image /page/4/Figure/12 description: The image shows a Michael Todd Clear BIIGHT device with its charger stand. The device has a treatment head with LEDs covered by clear polycarbonate, which is referred to as the treatment head face. The device also has a power on/off button with an indicator light, a treatment head release lever, and a DC input for charging.
F. Indication for Use:
The Clear Bi-Light is indicated for the treatment of mild to moderate inflammatory acne.
5
Section 8: 510(k) Summa
Technical Comparison with Predicate Devices க்
nformation for predicate devices was obtained from publicly available sources, including the 510(k) Summaries and device
nstruction manuals.
| | Indication for Use | OTC or Rx? | Energy source | Treatment heads | Wavelength(s) (nm) | Comparison | | Clear Bi-Light | Tanda Mini*
K124042 | Silkn Blue
K121435 | OmniLux Clear U
K081307 | Comparison |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|------------|---------------|---------------------------------------------------------|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Clear Bi-Light | Indicated for the treatment of mild to moderate inflammatory acne. | OTC | LED | Separate Blue and Red, treatment heads | 405-420
630-660 | | Treatment
control(s) | On/off button puts
device in standby
mode
Contact sensor in
treatment face,
touching device to
face activates LEDs | On/off button puts
device in standby
mode
Contact sensor in
treatment face,
touching device to
face activates LEDs | On/off button | Three position
switch: Off - Blue
- Red | All devices have
on/off button.
Contact sensor in
proposed device is
the same as in the
Tanda Mini. |
| Tanda Mini* K124042 | Generally indicated to treat dermatological conditions. Specifically, Blue light modules are indicated to treat mild to moderate inflammatory acne. | OTC | LED | Blue only | $414 \pm 6$ | | Treatment
indicator(s) | Indicator light - Solid
green while
treatment is in
process; blinking
indicates low battery.
Audio signal: long
beep when power is
turned on, short beep
every 30 seconds
during treatment;
long beep at end of 3
minute cycle | Indicator light -
flashing green when
treatment is being
delivered
Audio signal: one
beep every 30
seconds during
treatment; 2 beeps
at end of treatment
or low battery; 3
beeps signals high
temperature on
treatment head; 4
beeps signals
treatment head is
disconnected. | Indicator light -
Solid green when
ready for treatment
or battery fully
charged; blinking
green for low
battery; orange for
battery charging; | None | Indicator light
substantially
equivalent to Tanda
Mini and Silkn Blue.
Audio signal
substantially
equivalent to Tanda
Mini |
| Silkn Blue K121435 | Indicated as an over the counter phototherapy device for the treatment of mild to moderate acne. | OTC | LED | Blue only | $415 \pm 15$ | Same | Treatment
timer | Yes
Up to 3 minute
treatment per area
after which device
returns to standby
mode. Must press
treatment face
against skin to
reactivate lights | Yes
Up to 3 minute
treatment per area
after which device
turns off. Must
press power button
to reactivate. | No | No | Substantially
equivalent to Tanda
Mini. Both devices
limit each treatment
to 3 minute
segments. |
| OmniLux Clear U K081307 | Indicated to treat mild to moderate acne on the face. | OTC | LED | Blue and Red in same head, chosen using selector switch | $415 \pm 5$
$633 \pm 6$ | Substantially equivalent. Minor wording differences do not change indication for use. | | | | | | |
| | | | | | | Same as OmniLux (both offer separate blue and red light treatments). All devices offer blue light treatments. Substantially equivalent. Wavelengths are in the blue and red spectrum. | | | | | | |
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Page 4 of 7
Section 8: 510(k) Summar
Michael Todd, LP
Clear Bi-Light 510(k)
7
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| 2 | |
| 2 | |
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Page 5 of 7
| Treatment
regimen | Clear Bi-Light | Tanda Mini*
K124042 | Silkn Blue
K121435 | OmniLux Clear U
K081307 | Comparison |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Dose rate
(mW/cm²) | 31.1 (blue)
54.6 (red) | 22.4 | 50 | 40 (blue)
70 (red) | Substantially equivalent. Proposed treatment regimen is essentially the same as for Tanda Mini and Silkn Blue |
| Treatment face
area (cm²) | 20 | 27 | 7 | 28.7 | Substantially equivalent - within dose rate ranges of predicate devices |
| Max treatment
temperature
(°C) | 38°C (blue)
40°C (red) | 39-43 | 41 ± 2 | 39-43 | Substantially equivalent - within size ranges of predicate devices |
| Microprocessor
controlled | Yes | Yes | Yes | Unknown | Substantially equivalent - within temperature ranges of predicate devices |
| Handheld | Yes | Yes | Yes | Yes | Same |
| Patient
contacting
materials | Rigid ABS
Clear polycarbonate
lens cover | Rigid ABS | Stainless steel
Rigid ABS | Rigid ABS | Substantially equivalent.
Biocompatibility compliant with ISO 10993. |
| Treatment
regimen | Hold treatment face
in contact with skin.
Apply blue light for
up to 3 minutes per
skin area, followed
by red light for up to
3 minutes per skin
area. Can be used
daily. | Hold treatment face
in contact with skin
and apply blue light
for up to 3 minutes
per skin area. Can
be used daily | Hold treatment face
in contact with skin
for 3 to 4 minutes,
then move to
another area. Can
be used daily. | Alternate
treatments of blue
and red light twice
a week for 20
minutes per
treatment | Same |
| | Clear Bi-Light | Tanda Mini*
K124042 | Silkn Blue
K121435 | OmniLux Clear U
K081307 | Comparison |
| Power supply | Lithium-ion rechargeable battery
AC charger: 100-240V at 50-60Hz, 500 mA | NiMH rechargeable battery or AC power supply
AC charger: 100-240V, 50-60 Hz, 400 mA | Lithium-ion rechargeable battery
AC charger: 100-240V, 50-60 Hz, 400 mA | "A separate, universal, power supply converts mains AC power to the DC power required" | Same as Silkn Blue |
| Dimensions | 6.4 cm x 3.5 cm x 14.6 cm
(2.5 in x 1.4 in x 5.7 in) | 6.4 cm x 5.6 cm x 12.2 cm
(2.5 in x 2.2 in x 4.8 in) | 7.5 cm x 5 cm x 16.4 cm
(3 in x 2 in x 6.5 in) | 6 cm x 4 cm x 12 cm
(2.4 in x 1.6 in x 4.7 in) | Substantially equivalent. All are small, hand-held devices. |
| Weight | 107.1 g (6 oz) | 340.2 g (12 oz) | 231 g (8.1 oz) | Unknown | Substantially equivalent. All are light-weight, hand-held devices. |
8
ection 8: 510(k) Summa
There are e indication for use of the Clear Bi-Light device is the same as the technical specification
the Clear Bi-Light device are either the same or substantially equivaled the pred
9
H. Nonclinical Testing
The following nonclinical testing was provided in this 510(k):
Biocompatibility Testing - The skin contacting material of the device (hydrogel) was subjected to biocompatibility testing per ISO 10993-1:2009, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing," for devices in contact with intact skin, including cytotoxicity, dermal sensitization, and dermal irritation. All tests passed.
Electrical Safety and Electromagnetic Compatibility Testing - The Clear Bi-Light has been tested and complies with the applicable requirements of the following standards for medical devices used in the home environment:
- . IEC 60601-1:2005 Medical Electrical Equipment - Part 1: General Requirements for Safety, 3rd edition
- IEC 60601-1-2:2007 Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests, 300 edition
Photobiological Safety Testing - The Clear Bi-Light has been tested and complies with IEC 62471:2006-07, Photobiological safety of lamps and lamp systems, 186 edition. This IEC standard incorporates the principles of the following ANSI IESNA recommended practices:
- o RP 27.1:2005 Recommended practice for photobiological safety for lamps and lamp systems - General requirements
- RP 27.2:2000 Recommended practice for photobiological safety for lamps and lamp systems - Measurement techniques
- RP-27.3:2007 Recommended practice for photobiological safety for lamps ● and lamp systems - Risk group classification and labeling
Software Verification and Validation - Software documentation consistent with moderate level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
I. Conclusions
The information and testing presented in this 510(k) demonstrates that the Clear Bi-Light performs as designed and intended and is substantially equivalent for the treatment of mild to moderate inflammatory acne.