The Cellulize is a non-invasive green light system with a power output of 105mW/cm2, consisting of 150 light emitting diodes (LEDs) that emit visible light at nominal wavelength of 532nm ± 3nm (visible green light spectrum) and a spectral bandwidth of 10nm. Cellulize® is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs. The Massager component is indicated for the temporary reduction in the appearance of cellulite.

The components of the device include a mobile pole cart, controller console which plugs into a hospital-grade isolation transformer (attached with a bracket clamp to the pole cart), LED array mounted on an articulated arm (attached with a bracket clamp to the mobile pole cart), digital timer pre-selected for 8-minutes or 20-minutes, on/off switch, and a hospital-grade power cable. The articulated arm allows the light fixture to be positioned in a wide variety of functional positions. The knuckles and joints on the arm allow the light fixture to be rotated, tilted, and raised/lowered independently. The timer is set to a preset value of 8 minutes for circumference reduction treatment via a validated internal timer delay relay. The light fixture is positioned 17cm (6.8″) from the patient's skin to deliver the standard dose output intensity of 105mW/cm-and standard energy dose of 50 J/cm² with 8 minutes. Cellulize does not use any software.

AI/ML Overview

This document describes the acceptance criteria and the study that proves the Cellulize device meets these criteria for its indication as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the Cellulize device directly relates to its ability to achieve inch loss. The primary outcome measure for the clinical study was "Average Change in Inches of Total Circumference Measurements for effect of Cellulize, a LED 532nm green light low level laser system for aesthetic use for the non-invasive reduction in fat layer for body contouring from baseline measurements, and after treatment."

Acceptance Criteria	Reported Device Performance (Cellulize Active Group)
Primary Outcome: Demonstrate immediate inch loss in subjects after a regimen of six treatments of 32 minutes (8 minutes on each of four positions) compared to individuals subjected to a placebo device for an equivalent treatment.	Mean Cumulative Inch Loss: 2.67 inches (calculated from "before" treatment).
Durability of Effect: Demonstrate continued inch loss upon following up with each subject at 7 days and again at 14 days, indicating a sustained effect.	Mean Cumulative Inch Loss at 7-days: 3.40 inches. Mean Cumulative Inch Loss at 14-days: 3.87 inches. Additional Average Loss after time: 0.73 inches (from "after" to "7-day") and 0.47 inches (from "7-day" to "14-day"). This implies active Cellulize patients continued losing an average of 1.20 inches for a total average inch loss of 3.87 inches after 14 days.
(Failed) Reduction in the appearance of cellulite: Demonstrate a decrease in the appearance of cellulite as measured by the Nurnberger-Muller Scale (NMS) from baseline to completion of treatment for the thigh/buttock area using Cellulize LED 532nm green light without any other intervention.	The Nurnberger-Muller Scale (NMS) results from the active device as well as placebo both showed that cellulite in general did not decrease on the back of thigh/buttocks for subjects after a single treatment. This failed to meet the anticipated primary outcome measure.

Note: The FDA 510(k) clearance is based on the substantial equivalence of the device, which in this case relies on meeting the inch loss criteria, even though the cellulite reduction criterion was not met. The legally marketed predicate devices support the inch loss claim.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: A total of 52 patients participated in the clinical study.
- 25 patients were in the Active Cellulize group.
- 27 patients were in the Placebo Control group.
Data Provenance: The document does not explicitly state the country of origin of the data. However, given the FDA submission, it can be inferred that the study was conducted to meet U.S. regulatory standards. The study was a prospective, double-blind, placebo-controlled randomized evaluation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not provide details on the number or qualifications of experts used to establish the ground truth for the test set. For objective measurements like circumference reduction, the "ground truth" would typically be derived from direct, quantitative measurements rather than expert consensus on subjective interpretation. For cellulite reduction using the Nurnberger-Muller Scale (NMS), the scale itself is an industry standard and implies a structured assessment, likely by trained personnel, but their specific qualifications or number are not mentioned.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1) for establishing the ground truth measurements. As direct measurements were taken, an adjudication process for subjective interpretation might not have been deemed necessary or explicitly documented. The study was double-blinded, meaning neither the participants nor the measurement takers (to the extent possible) would know if the active or placebo device was being used, which inherently reduces bias.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, nor is there information on the effect size of how much human readers improve with AI vs. without AI assistance. This type of study is more common for diagnostic AI tools where human interpretation is the primary endpoint. For a device like Cellulize, the effectiveness is measured by physical changes (circumference reduction), not by human perception of diagnostic images.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The Cellulize device does not use any software for its operation (as stated in Section 14, "No Software" and the comparison table, item 3). Therefore, a standalone (algorithm-only) performance study is not applicable. The device's efficacy is based on the direct application of green light, and the study evaluated the device's physical effect on the body with human subjects.

7. Type of Ground Truth Used

The ground truth used for the primary outcome measure (inch loss) was direct, quantitative measurements of cumulative circumferences of the waist, hip, and thighs. These measurements were taken "before" and "after" treatment, as well as at 7-day and 14-day follow-ups.

For the assessment of cellulite, the Nurnberger-Muller Scale (NMS), a four-stage scale, was used as an industry standard. This would be a form of clinical assessment or qualitative measurement.

8. Sample Size for the Training Set

The document describes a clinical study in support of the 510(k) submission, which is typically a validation study (test set). There is no information provided on a separate training set or its sample size. Devices like Cellulize that do not use software or AI/machine learning models typically do not have a "training set" in the computational sense. The design and parameters of the device (such as wavelength, power output, treatment time) are based on scientific principles and potentially prior research or predicate device characteristics, which serve as the "training" for the device's physical design and treatment protocol.

9. How the Ground Truth for the Training Set Was Established

As noted above, there is no explicit "training set" in the context of an AI/ML model for this device. The physical design and treatment protocol would have been established through a combination of:

Bench Testing: As described in the document (e.g., IEC 60601-1-2 EMC Test Report, IEC 62471 Photobiological Safety, Device Life Report), these tests validate that the system meets design specifications and performance requirements.
Scientific Principles and Prior Knowledge: The device utilizes 532nm green light, which is also used by a predicate device (Verju Laser) that causes lipolysis. This indicates that the foundational scientific understanding of how such light interacts with biological tissue to achieve the desired effect informed the device's design.
Predicate Device Comparison: Extensive comparison to predicate devices (Verju Laser and Photonica Professional) was performed to establish substantial equivalence in design, operation, and intended use, effectively leveraging the "ground truth" demonstrated by those previously cleared devices.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are simple and professional in appearance.

September 21, 2018

Ward Photonics LLC % Jeff Brown Senior Consultant Jeff Brown Lifescience 1260 Bell View Circle Sandy, Utah 84094

Re: K180338

Trade/Device Name: Cellulize Regulation Number: 21 CFR 878.5400 Regulation Name: Low Level Laser System for Aesthetic Use Regulatory Class: Class II Product Code: OLI Dated: February 7, 2018 Received: February 7, 2018

Dear Jeff Brown:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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

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Indications for Use

510(k) Number (if known) K180338

Device Name Cellulize

Indications for Use (Describe)

Cellulize® is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.

The Massager component is indicated for the temporary reduction in the appearance of cellulite.

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)

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Section 6 - 510(k) Summary For

Cellulize

1. Submission Sponsor

Ward Photonics LLC 1980 N. Atlantic Avenue, Ste. 1030 Cocoa Beach, FL 32931 USA Phone: 1-800-392-5950 Fax: 1-800-392-5950 Contact: Terry Ward, Managing Director

2. Submission Correspondent

Jeff Brown Lifescience 1260 Bell View Circle Sandy, UT 84094 Telephone: (801) 633-9660 Contact: Jeff Brown, Managing Partner Email: jeffbrown144@gmail.com

3. Date Prepared

September 20, 2018 (revised submission 180920-3)

4. Device Identification

Trade/ProprietaryName:	CELLULIZE	Pure Wave Massager
Common/Usual Name:	Fat Reducing Low Level Laser	Massager, Therapeutic, Manual
Classification Name:	Low level laser system foraesthetic use	Therapeutic massager
ClassificationRegulation:	878.5400	890.5660
Product Code:	OLI	LYG
Device Class:	Class II	Class I
Classification Panel:	General & Plastic Surgery	Physical Medicine

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510k Summary Revised 9/14/2018

5. Class II Special Controls for Low Level Laser System for Aesthetic Use

The guidance document, "Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use," outlines the special controls, along with general controls, that are sufficient to provide reasonable assurance of the safety and effectiveness of the low level laser system for aestheticuse. Therefore, this submission and supporting exhibits will show that (1) Ward Photonics, and Cellulize, conform to the general controls of the Federal Food, Drug & Cosmetic Act (the FD&CAct), including the premarket notification requirements described in 21 CFR 807 Subpart E, (2) the specific risks to health associated with the low level laser system for aesthetic use identified in the guidance are addressed, and (3) Cellulize is substantially equivalent to the predicate device.

6. Photographs and Drawings of the Device

Cellulize is generally described as a pole-mounted freestanding device as shown in the photo to the right. The device is described in greater detail using a series of schematic drawings attached as Exhibits 13B (1-7).

7. Legally Marketed Predicate Device(s)

The Cellulize is substantially equivalent to the following predicate devices:

Verju Laser, (K130922) by Erchonia Corporation. .
. Photonica Professional, (K160880) by Ward Photonics.

8. Device Description

power cable. The articulated arm allows the light fixture to be

Image /page/4/Picture/15 description: The image shows a Cellulize light therapy device on a stand. The device has a square light panel attached to a vertical pole. The pole is attached to a base with wheels, making it portable. The Cellulize logo is visible on the control box.

Cellulize pole mounted freestanding device.

positioned in a wide variety of functional positions. The knuckles and joints on the arm allow the light fixture to be rotated, tilted, and raised/lowered independently. The timer is set to a preset value of 8 minutes for circumference reduction treatment via a validated internal timer delay relay. The light fixture is positioned 17cm (6.8″) from the patient's skin to deliver the standard dose output intensity of 105mW/cm-and standard energy dose of 50 J/cm² with 8 minutes. Cellulize does not use any software.

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9. Indication for Use Statement

Cellulize® is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.

The Massager component is indicated for the temporary reduction in the appearance of cellulite.

10. Risk of Ocular Injury

Cellulize was subjected to bench testing in order to demonstrate that the system meets all design specification and performance requirements.

. IEC 60601-1-2: 2007, EMC Test Report (Exhibit 17B), characterizes the output beam profile and establishes that the light energy from the LEDs is delivered and concentrated in the desired target location.
IEC 62471 SGS 04-2014, Photobiological Safety of lamps and lamp systems, (Exhibit 77C) . was conducted in regard to power and performance of the LEDs, power measurements to demonstrate that the LED output power, specifically that reaching the target site, is predictable.
Device Life Report (Exhibit 16A) confirms proper performance to design specifications and assess the probability of system failure, the means by which system failure can be mitigated, and the means by which system failure is apparent to the user.
Risk assessment (Exhibit 18B1-3), assess the failure modes and probabilities.

11. Labeling

Cellulize labeling has been included as Exhibit 15B. Likewise, the Cellulize User manual is included as Exhibit 67. IEC60601-1, Medical electrical equipment (Exhibit 17A) among other things addresses the legibility of marking and durability of marking. All Cellulize labeling satisfies the requirements of 21 CFR 807.87(e) and includes the following elements:

. Descriptions of:
- . the device and all accessories
- . how the device interconnects with other components or accessories
- all features, functions, output modalities, and specifications
- . all user-accessible controls
- indicators, markings, and/or labels on the device which provide information regarding the function or meaning of each control, display output jack, etc.
- illustrations of the device and accessories
Directions for Use ●
Indications for Use, including Contraindications
Storage Conditions
Warnings
Precautions
- . Need for protective eye wear during use
- Electrical Shock
- Unintended Cell Damage
- Use Error

12. Electrical Shock and Basic Safety

IEC 60601, Medical electrical equipment (Exhibit 17A), was conducted to show

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Electrical and Mechanical Safety Performance, and IEC 60601-2-57, Medical electrical equipment (Exhibit 17D), was conducted for particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use

13. Unintended Cell Damage

Bench Testing was conducted in IEC 62471 SGS 04-2014, Photobiological Safety of lamps and lamp systems (Exhibit 17C). Cellulize passes all applicable tests.

14. Software Validation

No Software.

15. Clinical Testing

A clinical study was conducted, and is submitted in support of the 510(k) submission. The study was a double-blind, placebo-controlled randomized evaluation of the effect of Cellulize for aesthetic use for the non-invasive reduction in fat layer for body contouring and reduction of cellulite. A total of 52 patients participated in the study (25 Active Cellulize, and 27 Placebo Control). Patients were all female with a median age of 42.5 years old with a range of patient ages from 18 years to 69 years old. Ethnic origin of the patients were represented from Asian, African American, Caucasian, Latino, and Pacific Islander. Cumulative circumferences of waist, hip, left and right thighs for each patient was calculated before and after treatment. Three main points were concluded as a result of the study:

1. Cellulize causes immediate inch loss in subjects after a regimen of six treatments of 32 minutes (8 minutes on each of four positions) compared to individuals subjected to a placebo device for an equivalent treatment. In a typical regimen, patients lost an average cumulative 2.67 inches of circumference compared to placebo average of 0.5 inch. This meetsthe anticipated primary outcome measure "Average Change in Inches of Total Circumference Measurements for effect of Cellulize, a LED 532nm green light low level laser system for aesthetic use for the non-invasive reduction in fat layer for body contouring from baseline measurements, and after treatment." Figure 1, below, shows the graphical summary of inch loss for patients in the Cellulize active group and the Placebo control group respectively. Table 1 give the mean values for both groups as well as standard deviation for the "after" measurements, as well as 7-day and 14-day follow ups relative to the "before" measurements for each patient.

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Image /page/7/Figure/3 description: The image contains two bar charts, one labeled "Cellulize" and the other "Placebo". Both charts depict "Inch Loss" on the y-axis, ranging from -9 to 16, and "Patient ID#" on the x-axis. Each chart shows three data series: "After", "7-day", and "14-day", represented by different colored bars for each patient ID.

Figure 7-1 - Patient inch loss/gain results comparison. Cellulize patients had significantly better cumulative inch loss than patients who received a placebo treatment using a sham device. The initial measurement after completing the treatment regimen (blue) is often followed by continued loss 7 days (red) and 14 days (yellow) after completing all treatment. Patients undergoing placebo procedure exhibited unpredictable gains or losses consistent with untreated patients, and the amplitude of the changes is smaller than patients treated with Cellulize.

Celluize Active Group	After	7-day	14-day
Mean Cumulative Inch Loss (calculated from "before"):	2.67	3.40	3.87
Standard Deviation:	4.04	3.81	4.45
Min Inches Lost:	-9.88	-2.25	-1.88
Max Inches Lost:	10.00	12.38	15.00
Additional Average Loss after time:	-	0.73	0.47
Placebo Group	After	7-day	14-day
Mean Cumulative Inch Loss (calculated from "before"):	0.52	0.07	-0.82
Standard Deviation:	2.61	2.72	2.95
Min Inches Lost:	-6.88	-5.38	-8.63
Max Inches Lost:	6.13	4.88	4.00

Table 7-1: Inch Loss summary for Cellulize active Trial Participants and Placebo Trial Participants. The demonstrated inch loss, as well as continued effect, were greater and were general ly desirable effect for the Cellulize Group. The placebo group had minimal effect and inch gain was more prevalent among participants.

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ATTACHMENT 1

Ward Photonics, LLC Traditional 510(k) Premarket Submission Cellulize

1. While durability of effect is also impacted by extrinsic factors after treatment such as diet, it was demonstrated that subjects were more likely to show continued inch loss upon following up with each subject at 7 days and again at 14 days. In general, patients undergoing active Cellulize 532nm green light continued losing some inch with an average continued loss of an addition 1.20 inches for a total average inch loss of 3.87 inches where average placebo measurements after 14 days yielded a net gain (not a loss) of 0.875 inches. This implies that the green light treatment meets the expected primary outcome of demonstrated durability of effect after short-term follow up of 2weeks.
1. Finally, the effect of Cellulize LED 532nm green light without any other intervention was measured for its effect on cellulite as part of the study. The Nurnberger-Muller Scale (NMS), a four-stage scale used as an industry standard to classify stage or degree of cellulite and to determine change in stage or degree of cellulite following treatment intervention, was used to ensure consistent evaluation standards. Results from the active device as well as placebo both showed that cellulite in general did not decrease on the back of thigh/buttocks for subjects after a single treatment of 532nm green light. This result failed to meet the anticipated primary outcome measure of decreasing appearance of cellulite as a measure of the Nurnberger-Muller Scale (NMS) from baseline to completion of treatment for the thigh/buttock area.

16. Biocompatibility

Non-Patient Contact

1. Electromagnetic Compatibility IEC 60601-1-2 (Exhibit 17B)

18. Use Error

Addressed in Labeling (see above).

19. Substantial Equivalence

Cellulize, with its intended use, is equivalent to the predicate devices:

. Verju Laser, manufactured by Erchonia. The K130922 clearance is attached as Exhibit 14A.
Photonica Professional, manufactured by Ward Photonics. The K160880 clearance ● is attached as Exhibit 14B.

Both of the predicate devices, as well as the candidate device, cause lipolysis, which reduces the circumferences as a result of exposure to 532 nm green light (or 635nm red light). Cellulize, is a circumference reducing LED light system using 532nm ± 3nm green light which is the same green light wavelength used by the VERJU.

The FDA product classification code, OLI, has a guidance document which is the special control for this product, Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use. According to the guidance document, FDA believes that special controls, when combined with the general controls, will be sufficient to provide reasonable assurance of the safety and effectiveness of the low level laser system for aestheticuse. Cellulize complies with all of the standards outlined in the special controls consensus standards.

The principles of operation and base elements of the Cellulize device are very similar to the

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Verju predicate device in the portability, and pole-mounted positioning over the patient; however, the Verju utilizes a different mechanism to achieve coverage of the treatment area with green light. The predicate Verju Laser utilizes six pin-point lasers positioned on articulating arms circumferentially positioned around the treatment area. The rotating lasers of the Verju project a concentrated high intensity green line over a small portion of the treatment area, and the system rotates to effectively cover a broad pattern, or to "scan" the treatment area for its coverage. Cellulize achieves treatment area coverage through a soft uniform bath of green light from an array of 150 diodes. Because "dosage" is a mechanism of energy, coverage and time, the Cellulize has matched the effectiveness of the predicate with LED green light to provide the same treatment. The table below details the similarities of the predicate to Cellulize. There are no differences between the subject device and the Verju Laser with respect to indications and intended use.

The Cellulize device is based upon the same design platform as the Photonica Professional predicate device in every aspect of the design except for the color of the LED array. Cellulize uses 532nm green light, and Photonicia Professional uses 635nm red light.

The Cellulize is substantially equivalent to the Verju Laser manufactured by Erchonia and subject of (K130922), as well as the Photonica Professional manufactured by Ward Photonics and subject of (K160880). Table 7-1 (below – refer to Section 13), gives the comparison between the two predicate devices and the candidate device.

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Table 7-2 – Comparison to legally marketed predicate device (ref: Section 13, Substantial Equivalence).

Manufacturer	Erchonia Corporation	Ward Photonics LLC	Ward Photonics LLC	SignificantDifferencesVerju vs Cellulize	SignificantDifferencesPhotonica vs Cellulize
Trade Name	PredicateVerju Laser	PredicatePhotonica Professional	New DeviceCellulize
510(k) Number	K130922	K160880	TBD
Product code	OLI	OLI	OLI	No Difference	No Difference
Regulation Number	878.5400	878.5400	878.5400
		Clinical / Design Features
1.Indications forUse	Device is indicated for use asa non-invasive dermatologicalaesthetic treatment as anadjunct for individualsintending to undergoliposuction procedures for thereduction of circumference ofhips, waist, and thighs.	Device is indicated for use asa non-invasive dermatologicalaesthetic treatment for thereduction of circumference ofhips, waist, and thighs.	Cellulize is indicated for use asa non-invasive dermatologicalaesthetic treatment for thereduction of circumference ofhips, waist, and thighs.	No difference exceptthat Verju indicationadds adjunct purposeof preparingindividuals forliposuctionprocedures.NOTE: Verju websitedoes not mentionadjunct purpose intheir marketing.	No Difference
2.Continuous orPulsed	Continuous	Continuous	Continuous	No Difference	No Difference

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ManufacturerTrade Name		Erchonia CorporationPredicateVerju Laser	Ward Photonics LLCPredicatePhotonica Professional	Ward Photonics LLC	SignificantDifferencesVerju vs Cellulize	SignificantDifferencesPhotonica vs Cellulize
				New DeviceCellulize
3.	Software Used?	Y – Verju has been marketedin the United States withvarious software operatingsystems, including some thatincorporate pay-per-usefeatures. All versions providea 20-minute timer for thefront and then 20 minutes forthe back and operate usingtouch screen buttons.	N – Photonica is controlled bymanual settings.	N – Cellulize is controlled bymanual settings.	Cellulize is simplerwithout complexsoftware to trackusage and billingfunctions.	No difference
4.	Adjustable LightPositioning?	Y – articulated arms allow formany adjustments.	Y – articulated arm allows formany adjustments.	Y – articulated arm allows formany adjustments.	No Difference	No Difference
5.	Non-invasive?	Y	Y	Y	No Difference	No Difference
	Safety Features
6.	PatientProtectiveEyewearIncluded?	N	Y – one box of 50 pairs ofKentek IPL SmartShielddisposable eye protection areincluded	Y – one box of 50 pairs ofKentek IPL SmartShielddisposable eye protection areincluded	Cellulize includespatient protectiveeyewear.	No Difference
7.	OperatorProtectiveEyewearIncluded?	Y – provides one pair of itsprivate label branded operatorprotective eyewear	Y – one pair for the operator(Kentek IPLSAFE)	Y – one pair for the operator(Kentek IPLSAFE)	No Difference	No Difference

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	Manufacturer	Erchonia Corporation	Ward Photonics LLC	Ward Photonics LLC	SignificantDifferencesVerju vs Cellulize	SignificantDifferencesPhotonica vs Cellulize
	Trade Name		PredicatePhotonica Professional	New DeviceCellulize
8.	Power protection	Unknown	Isolation transformerseparates facility power fromthe device. Power switch thatcancels the treatment (lowestrisk; key switch not requiredby IEEC standards).	Isolation transformerseparates facility power fromthe device. Power switch thatcancels the treatment (lowestrisk; key switch not requiredby IEEC standards).	Not available forcomparison.	No Difference
	Light Emissions Specifications
9.	Peak Wavelength	532nm (visible green lightspectrum)	635nm ±2nm (visible red lightspectrum)	532nm ±3nm (visible greenlight spectrum)	No Difference	Predicate Photonicauses red light.
Manufacturer	Erchonia Corporation	Ward Photonics LLC	Ward Photonics LLC	SignificantDifferences	SignificantDifferences
Trade Name	PredicateVerju Laser	PredicatePhotonica Professional	New DeviceCellulize	Verju vs Cellulize	Photonica vs Cellulize
10. Total PowerOutput	102 mW Using (6) 17mWLaser-Emitting Diodes (Lasers)	240 W Using (150) 1600 mWLight-Emitting Diodes (LEDs)	240 W Using (150) 1600 mWLight-Emitting Diodes (LEDs)	The cumulative totalpower output ofCellulize with 150 LEDsis greater than thecumulative poweroutput of Verju withsix lasers.	No Difference
Manufacturer	Erchonia Corporation	Ward Photonics LLC	Ward Photonics LLC	SignificantDifferencesVerju vs Cellulize	SignificantDifferencesPhotonica vs Cellulize
Trade Name	PredicateVerju Laser	PredicatePhotonica Professional	New DeviceCellulize
11. Outputintensity/Irradiance(mW/cm²)	0.20 mW/cm²	105 mW/cm²	95.14 mW/cm²	The Verju delivers allof its energy to asingle point on the skinand uses scanning todistribute the power.At the point on theskin where the laser isfocused, the laser ismore powerful thanthe light from Cellulize,but because the Verjuis continuously movingthe active pinpointwith a scanningmotion, the totalphotonic energy(luminous flux)delivered to the fatcells is much lowerthan Cellulize.	Essentially the same
Manufacturer	Erchonia Corporation	Ward Photonics LLC	Ward Photonics LLC	SignificantDifferencesVerju vs Cellulize	SignificantDifferencesPhotonica vs Cellulize
Trade Name	PredicateVerju Laser	PredicatePhotonica Professional	New DeviceCellulize
12. StandardTreatment Time(minutes)	Two 15-minute exposures(front and back) at each 30-minute treatment session. Thestandard protocol is threesessions a week for two weeksas determined by the doctor.	Four 8-minute exposures(front, back, left, and right), 32-minute total per treatmentsession. The standard protocolis one session, taking the"before" and "after"measurements at the sameoffice visit.	A treatment regimen consistsof six sessions over a 2-weekperiod.Each treatment is four 8-minuteexposures (front, back,left, and right), 32-minute totalper treatment session.	Cellulize achieves inch-loss results in oneregimen of six 32-min.treatments.Verju standardprotocol uses six 30-minute treatments toachieve similar results	Cellulize achieves inch-loss results in oneregimen of six 32-min.treatments.Photonica standardprotocol measurestreatment results aftersingle visit.
13. MaximumCoverage Area(cm²)	516 cm² maximum totalcoverage area with 6 scanninglasers operating 8" from theskin	2294.0 cm² maximum totalcoverage area with 150 LEDsoperating 6.8" from the skin	2294.0 cm² maximum totalcoverage area with 150 LEDsoperating 6.8" from the skin	Cellulize providesuniform illuminationof 2294 cm² for theentire treatment time.Verju uses six laserheads scanning areasof 80 cm² for a total of516 cm².	No difference
Overall Device Specifications
14. Unit Dimensions(H x W x D)	170.2 cm x 78.74 cm x 154.9cm	183.2 cm x 62.2 cm x 61 cm	183.2 cm x 62.2 cm x 61 cm	Both are similarlysized pole-mountedmobile systems withlights attached toarms and four castersfor mobility.	No difference
Manufacturer	Erchonia Corporation	Ward Photonics LLC	Ward Photonics LLC	SignificantDifferencesVerju vs Cellulize	SignificantDifferencesPhotonica vs Cellulize
Trade Name	PredicateVerju Laser	PredicatePhotonica Professional	New DeviceCellulize
15. Weight (kg)	32 kg	52 kg (with carton)	52 kg (with carton)	The Cellulize includesthe safety benefit ofan isolationtransformer thatalone weighs 7.7 kg.It is unknown if theweight of theshipping carton isincluded in the valueprovided for thepredicate.	No difference
16. Power Source	100-240V, 0.5-1.5A, 50/60 Hz	100-120 VAC, 3A, 50/60 Hz	100-120 VAC, 3A, 50/60 Hz	No difference	No difference
17. Operating Temperature	Unknown, may be stored at upto 41°C	+5°C to 35°C	+5°C to 35°C	Similar, both complywith IEC 60601 safetystandard whichincludes operatingtemperatures andhumidity; intendedfor use in sameenvironmentalconditions.	No difference
18. Operating Humidity	Unknown	10% to 90% RH, non-condensing	10% to 90% RH, non-condensing	No difference	No difference
19. CoolingMechanism	None	Forced air ventilation	Forced air ventilation	No functionaldifference	No difference
20. Expected Use Life	Unknown expected useful life.Comes with a two-year limitedwarranty.	At least 8,700 hours(16,312 of the 32-minute treatmentsessions). Comes witha two-year warranty.	At least 8,700 hours(26,100 treatmentsessions). Comes witha two-year warranty.	Similar. Both devicescome with a two-year warranty.	No difference
Manufacturer	Erchonia Corporation	Ward Photonics LLC	Ward Photonics LLC	SignificantDifferencesVerju vs Cellulize	SignificantDifferencesPhotonica vs Cellulize
Trade Name	PredicateVerju Laser	PredicatePhotonica Professional	New DeviceCellulize
21. Meets the OLI"RecognizedConsensusStandard"	Yes	Yes	Yes	No difference	No difference
Major Device Components
22. Light Emitters	Verju has 532nm laser-emitting diodes onadjustable arms.	Cellulize has 635nm light-emitting diodes on anadjustable arm.	Cellulize has 532nm light-emitting diodes on anadjustable arm.	No difference	LEDs are red 635nminstead of 532nm
23. Base Unit	Contains the Control Unit:• LCD Display• Keyboard for user input• Control electronics• Power supply with aninterchangeable fuse	Contains the Control Console:• Power indicator lamp• Start button• Timer switch• Output connector to theLED Panel• Power entry module withtwo user replaceablefuses• Hours meter.	Contains the Control Console:• Power indicator lamp• Start button• Timer switch• Output connector to theLED Panel• Power entry module withtwo user replaceablefuses• Hours meter.	The predicate deviceis softwaredrivenand allows the userto select which lasersare active. Also usedto track usageminutes and chargeusers according toVerju fee structure.The Cellulize usesmechanical timers.	No difference
24. Mobile Cart	Y- mobile cartmounted system.	Y- mobile cartmounted system.	Y- mobile cartmounted system.	No difference	No difference
25. Arms	Y - A folding arm systemattaches the control unit tothe laser heads.	Y - A fully articulating armattaches to the mobile polecart and the LED Panel.	Y - A fully articulating armattaches to the mobile polecart and the LED Panel.	Essentially nodifference	No difference
Manufacturer	Erchonia Corporation	Ward Photonics LLC	Ward Photonics LLC	SignificantDifferencesVerju vs Cellulize	SignificantDifferencesPhotonica vs Cellulize
Trade Name	PredicateVerju Laser	PredicatePhotonica Professional	New DeviceCellulize
26. IsolationTransformer	Unknown	Y - A hospital-approvedisolation transformer toprovide additional protectionto the patient from touchvoltage -- reducing themaximum touch voltage by94%, from 0.8v to 0.046v.	Y - A hospital-approvedisolation transformer toprovide additional protectionto the patient from touchvoltage -- reducing themaximum touch voltage by94%, from 0.8v to 0.046v.	Unable to determine	No difference

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Substantial Equivalence Discussion

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Table 7-3 – Comparison to legally marketed predicate massager device (ref: Section 13, Substantial Equivalence).

Manufacturer		Erchonia Corporation	Pado, Inc.	SignificantDifferencesPercussor vs PureWave
Address		650 Atlantis RdMelbourne, FL 32904	28340 Avenue Crocker Unit 100Valencia, CA 91355
Trade Name		PredicatePercussor Therapeutic Massager	New DevicePureWave CM5
510(k) Number		K130922	N/A	No Difference. PureWave is Classexempt device. Percussor wasincluded in K130922 as a Class Icompanion device.
Product code		LYG / ISA	LYG / ISA
Regulation Number		890.5660	890.5660
1.	Indications forUse	The Massager component is indicated for thetemporary reduction in the appearance of cellulite.	The Massager component is indicated for thetemporary reduction in the appearance of cellulite.	No Difference
2.	Claims / ClinicalEfficacy	Percussion massage therapy	Percussion massage therapy	No Difference
3.		6 to 60 percussions per second
4.	Battery Powered	NO. Power cord to wall-mounted power source.	7.2V Lithium-ion 2200mA 18650 x 2 Cell	Percussor uses power cord.PureWaveis cordless.
5.	Charge Time	N/A	120 minutes	Percussor uses power cord.PureWaveis cordless.
6.	Variable SpeedRange	1 rpm - 3,600 rpm	1,500 rpm - 3,700 rpm	Essentially No Difference
Manufacturer	Erchonia Corporation	Pado, Inc.	SignificantDifferencesPercussor vs PureWave
Address	650 Atlantis RdMelbourne, FL 32904	28340 Avenue Crocker Unit 100Valencia, CA 91355
Trade Name	PredicatePercussor Therapeutic Massager	New DevicePureWave CM5
7. Motor Voltage	120V AC	7.2V, DC	Percussor uses power cord.PureWave is cordless.
8. Motor Max RPM	3600 Hz	3700 Hz	Nearly identical. PureWave slightexceeds Percussor.
9. Charger InputVoltage	100-120Vac, 50/60Hzonly	100V-240V, 50/60Hz, 0.4 A Max	PureWave allows 100 to 240 V.Percussor is 100 to 120V only.
10. Charger OutputVoltage	N/A	8.5V, DC, 1A	Percussor uses power cord.PureWave is cordless.
11. Power Indicator	N/A	YES - Green when fully charged	Percussor uses power cord.PureWave is cordless.
12. Product Warranty	2 Year	1 Year	Percussor warranty is longer.
13. MultipleAttachment Tips	Two Tips: One cone head tip, and one flat pad tip.NOTE: optional attachments available, notincluded.	Three Tips: One cone head tip, one six-point tip,and one flat pad tip.	PureWave includes an additionalstyle of tip for more functionality.
14. Hand-held	YES	YES	No difference
15. Software	NO	NO	No difference
Manufacturer	Erchonia Corporation	Pado, Inc.	SignificantDifferencesPercussor vs PureWave
Address	650 Atlantis RdMelbourne, FL 32904	28340 Avenue Crocker Unit 100Valencia, CA 91355
Trade Name	PredicatePercussor Therapeutic Massager	New DevicePureWave CM5
16. General Controls	YES	YES	No difference

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20. Non-Clinical Performance Data

Cellulize has been tested for all designated tests (as applicable) given in the Guidance document: Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use (Document issued on: April 14, 2011). A detailed review of the performance and safety testing is given in Section 017_Performance Testing – Bench.

21. Statement of Substantial Equivalence

The Cellulize is substantially equivalent to the Verju Laser manufactured by Erchonia and subject of K130922 as a 532nm green light non-invasive solution for the reduction of circumference of hips, waist, and thighs. Cellulize is also substantially equivalent to the Photonica Professional manufactured by Ward Photonics and subject of K160880, as a medical device shown to meet all of the special controls outlined in Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.

The information provided in this submission supports the substantial equivalence to the predicate device and that the system is safe and effective for its intended use.

Regulation Number and Section

§ 878.5400 Low level laser system for aesthetic use

(a)
Identification. A Low Level Laser System for Aesthetic Use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for noninvasive aesthetic use.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.