K Number

Device Name

Strialite

Manufacturer

Centre Light Solutions, LLC

Date Cleared

2016-02-24

(281 days)

Product Code

OHS ONE

Regulation Number

878.4810

Intended Use

Strialite is an over-the-counter device in the temporary reduction of redness in striae rubra (red stretch marks). Strialite does not remove the stretch marks but may improve their appearance.

Device Description

The Strialite is an over the counter (OTC) device utilizing a combination of light emitting diode (LED) lights and a heating element as a phototherapy/thermal treatment for the end users' stretch marks (striae). It is a hand-held, compact, lightweight device, designed to specifically treat and reduce the visible appearance of an individual's red stretch marks. A stretch mark is a defect in the skin caused by damaged collagen that occurs from rapid skin stretching, that may have a red appearance. The red LED light and heat work together to stimulate the skin at the cellular level to produce and repair collagen. As the damaged collagen tissue is gradually replaced, over time the appearance of the stretch mark is reduced. Typical areas for treatment are the abdomen, breasts, back, hips, and thighs. The recommended treatment schedule is two (2) 20-minute sessions a week for at least four (4) weeks. Strialite is intended for home use by adults under the age of 50 years. The Strialite device consists of a housing enclosure with an ergonomic handle, electronic circuit boards, treatment plate with a specific array of LED lights, thermal heating elements that generate temperature up to 105 degree F (40 degree C), touch control power button (On/Off), and a power cord. The flat LED panel, consisting of thirty-five (35) visible red LEDs in the 633 nm (±5nm) spectrum, is located on the base of the device, and directly contacts the area of skin to be treated. The device is provided non-sterile and reusable.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K013748

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical mechanisms of LED light and heat therapy, with no mention of AI or ML algorithms for image processing, diagnosis, or treatment personalization.

Therapeutic

Yes.
The device is intended for the temporary reduction of redness in striae rubra (red stretch marks) and works by stimulating the skin at a cellular level to produce and repair collagen, aiming to improve the appearance of stretch marks. This falls under the definition of a therapeutic device as it treats a condition (red stretch marks) to improve a health-related concern (appearance).

Diagnostic

The device is described as a treatment device for reducing the appearance of stretch marks, utilizing LED lights and heat. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

The device description explicitly states it is a hand-held device utilizing LED lights and a heating element, along with electronic circuit boards, a treatment plate, and a power cord. These are all hardware components, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Strialite device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs are used to examine specimens from the human body. The Strialite device directly treats the skin on the body.
IVDs are used to provide information for diagnosis, monitoring, or screening. The Strialite device is a therapeutic device intended to reduce the appearance of stretch marks.
The intended use and device description clearly state it's a phototherapy/thermal treatment applied externally to the skin.

The Strialite is a therapeutic device that uses light and heat to treat a skin condition. It does not involve the analysis of biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Strialite is an over-the-counter device in the temporary reduction of redness in striae rubra (red stretch marks). Strialite does not remove the stretch marks but may improve their appearance.

Product codes (comma separated list FDA assigned to the subject device)

ONE

Device Description

The Strialite device consists of a housing enclosure with an ergonomic handle, electronic circuit boards, treatment plate with a specific array of LED lights, thermal heating elements that generate temperature up to 105 degree F (40 degree C), touch control power button (On/Off), and a power cord. The flat LED panel, consisting of thirty-five (35) visible red LEDs in the 633 nm (±5nm) spectrum, is located on the base of the device, and directly contacts the area of skin to be treated. The device is provided non-sterile and reusable.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Typical areas for treatment are the abdomen, breasts, back, hips, and thighs.

Indicated Patient Age Range

adults under the age of 50 years.

Intended User / Care Setting

home use by adults

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)

Clinical study: A clinical study was conducted to assess the effect of Strialite on the temporary reduction of redness of the subjects' red stretch marks. Thirty of the 33 subjects enrolled completed the full series of 8 treatments over 4 weeks. Sixteen out of 30 subjects reported, upon selfassessment, improvement of the severity of the redness of their stretch marks of at least 2 grades when graded on a scale of 1 to 10 from baseline to post-treatment. As a secondary endpoint blinded photographic assessment was performed and the blinded evaluation identified 18 of the 30 subjects as demonstrating improvement. Two subjects that selfassessed as having the worst appearing lesions (grade 10) did not show any improvement throughout the study. No adverse effects were observed or reported during the study.

Usability study: The usability test consisted of two components:

Demonstrating the ability to read and comprehend the information in the Instructions
for Use and Quick Start Guide, based on survey questions asked by an interviewer.
Demonstrating correct simulated use of the device by following the Instructions for Use and Quick Start Guide, as observed and recorded by the trained interviewer.
The study showed that 39 of 40 (97.5%) subjects were able to read and comprehend the information in the Instructions for Use manual, and that 38 of 40 (95.0%) subjects were able to correctly demonstrate the six critical steps in the use of the Strialite.

Self-selection study: Forty-one (41) subjects were each given the device carton labeling to read in private. When interviewed, all responders correctly determined from the carton labeling that the device is used for stretch marks, and all but one correctly self-selected.

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.

K013748

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

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.

Summary

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles incorporated into its design.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 24, 2016

Centre Light Solutions, LLC % Ms. Audrey Swearingen Emergo Global Consulting, LLC 816 Congress Avenue, Suite 1400 August, Texas 78701

Re: K151337 Trade/Device Name: Strialite 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: ONE Dated: January 8, 2016 Received: January 12, 2016

Dear Ms. Swearingen:

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 devicerelated 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

Indications for Use

510(k) Number (if known) K151337

Device Name Strialite

Indications for Use (Describe)

Strialite is an over-the-counter device in the temporary reduction of redness in striae rubra (red stretch marks). Strialite does not remove the stretch marks but may improve their appearance

Type of Use (Select one or both, as applicable)
	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

_ | Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

for

Strialite™

1. Submission Sponsor

Centre Light Solutions, LLC 611 East Douglas Road Suite 108 Mishawaka Indiana, 46545 USA Phone: 574.612.3381 Contact: Ms. Carrie Colborn, Director of Operations

2. Submission Correspondent

Emergo Global Consulting, LLC 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: 512.818.3811 Office Phone: 512.327.9997 Fax: 512.327.9998 Contact: Audrey Swearingen, Director Regulatory Affairs Email: project.management@emergogroup.com

3. Date Prepared

February 19, 2016

4. Device Identification

Trade/Proprietary Name:	Strialite™
Common/Usual Name:	Light Emitting Diode (LED) device
Classification Name:	Laser surgical instrument for use in general and plastic surgery
and in dermatology.
Classification Regulation:	21 CFR 878.4810
Product Code:	ONE
Device Class:	Class II
Classification Panel:	General and Plastic Surgery

5. Legally Marketed Predicate Device(s)

Candela V Beam Pulse Dye Laser System, K013748

6. Device Description

7. Indications for Use Statement

Strialite is an over-the-counter device indicated for use in the temporary reduction of redness in striae rubra (red stretch marks). Strialite does not remove the stretch marks but may improve their appearance.

8. Substantial Equivalence Discussion

As shown in Table 5A below, Strialite has the same intended use and similar technological characteristics and principles of operation as the predicate device, the Candela V Beam, and therefore is substantial equivalent to the predicate device.

Manufacturer	Centre Light Solutions	Candela Corporation
Trade Name	Strialite	Candela V Beam Pulse Dye
Laser System	Comparison of
Significant Differences
510(k) Number	N/A	K013748	N/A
Product Code	ONE	ONE	Same
Regulation Number	878.4810	878.4810	Same
Regulation Name	Laser surgical instrument
for use in general and
plastic surgery and in
dermatology	Laser surgical instrument
for use in general and
plastic surgery and in
dermatology	Same
Intended Use	Over the counter light
device for use in
dermatology	Prescription light device
for use in dermatology	Strialite is for OTC use,
which is supported by
the usability and self-
selection studies, and
clinical data.
Manufacturer	Centre Light Solutions	Candela Corporation
Trade Name	Strialite	Candela V Beam Pulse Dye
Laser System	Comparison of
Significant Differences
Indications for Use	An over the counter device
indicated for use in the
temporary reduction of
redness in striae rubra.
Strialite does not remove
the stretch marks but may
improve their appearance.	A prescription device
indicated for use in
dermatology for the
treatment of striae.	The fundamental
technology and the
intended use to treat
stria rubra using and
heat and red light are
the same.
Hand-Held	Yes	Yes	Same
Patient Contact
Materials	Anodized aluminum
Plastic	Stainless steel
Plastic	Both devices utilize
materials commonly
used in medical devices
having limited skin
contact.
Sterile	No	No	Same
Single-Use	No	No	Same
Peak Emission
Wavelength	633 ± 5nm	595 ± 5nm	Both devices utilize
light in the red
spectrum.
Mechanism of
Action	Red light energy and dermal
heating increases local
circulation and collagen
production	Red light energy and
dermal heating increases
local circulation and
collagen production	Both devices use a
combination of red
light energy and heat
Software	No	Yes	To keep the user
functions simple, no
software is used in the
Strialite.
Recommended
Operating
Conditions	Room temperature	Room temperature	Both operate within
normal room
temperatures
Electrical Safety /
EMC Testing Passed	Yes	Yes	Same
Clinical Study	Yes	unknown	Strialite has been
shown to be safe and
effective for its
intended use.

Table 5A - Comparison of Characteristics

9. Non-Clinical Performance Data

As part of demonstrating safety and effectiveness of Strialite and to show substantial equivalence to the predicate device, Centre Light Solutions completed a number of tests. The Strialite passed all testing stated in Table 5B below as shown by the acceptable results obtained. These tests confirm that the output meets the design inputs and specifications and support Strialite's safety, performance and substantial equivalence to the predicate device.

Testing Type	Test Performed / Standard	Result
Design Verification	Strialite Over-Temperature Sensor
Verification Study	The Strialite shuts off when the plate
temperature exceeds 41 °C.
	Strialite Power Switch Reliability
Verification	The power switch of the device
successfully performed 500 ON/OFF
cycles.
	Strialite Overtemperature Sensor with
Runaway Resistors	In a single fault failure mode, the over-
temperature protection sensor shut-off
the heat well before the treatment
plate reached a hazardous temperature
(