Cellulize

K180338 · Ward Photonics, LLC · OLI · Sep 21, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K180338
• Device Name: Cellulize
• Applicant: Ward Photonics, LLC
• Product Code: OLI · General, Plastic Surgery
• Decision Date: Sep 21, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Cellulize is a non-invasive, pole-mounted aesthetic device using 150 LEDs to emit 532nm green light. It delivers a uniform bath of light to the patient's skin at a distance of 17cm, with a power output of 105mW/cm² and energy dose of 50 J/cm² over an 8-minute treatment cycle. The device includes an articulated arm for positioning and a hospital-grade isolation transformer. It is operated by a clinician in a clinical setting. The device is used to induce lipolysis for body contouring. The clinician positions the LED array over the target area (hips, waist, thighs) to deliver the light energy. The device also includes a handheld massager component for cellulite reduction. The output is purely physical (light energy/mechanical massage) and does not involve software-based analysis or decision support. The device benefits patients by providing a non-invasive method for circumference reduction.

Clinical Evidence

Clinical study: double-blind, placebo-controlled, randomized trial (n=52; 25 active, 27 placebo). Primary endpoint: cumulative circumference reduction of waist, hip, and thighs. Results: Active group showed mean cumulative loss of 2.67 inches after treatment, increasing to 3.87 inches at 14-day follow-up, compared to 0.52 inches (after) and -0.82 inches (14-day) in placebo. Cellulite reduction endpoint (Nurnberger-Muller Scale) was not met.

Technological Characteristics

Pole-mounted LED system; 150 LEDs; 532nm ± 3nm wavelength; 105mW/cm² irradiance; 50 J/cm² energy dose. Powered by 100-120 VAC via hospital-grade isolation transformer. Articulated arm for positioning. No software. Forced air cooling. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, and IEC 62471.

Indications for Use

Indicated for non-invasive dermatological aesthetic treatment for circumference reduction of hips, waist, and thighs in adults. Massager component indicated for temporary reduction in appearance of cellulite.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Verju Laser (K130922)
• Photonica Professional (K160880)

Reference Devices

• Percussor Therapeutic Massager (K130922)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|-----------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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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: [phone] Fax: [phone] Contact: Terry Ward, Managing Director

#### 2. Submission Correspondent

Jeff Brown Lifescience 1260 Bell View Circle Sandy, UT 84094 Telephone: [phone] Contact: Jeff Brown, Managing Partner Email: [e-mail]

### 3. Date Prepared

September 20, 2018 (revised submission 180920-3)

#### 4. Device Identification

| Trade/Proprietary<br>Name: | CELLULIZE | Pure Wave Massager |
|-------------------------------|---------------------------------------------|-------------------------------|
| Common/Usual Name: | Fat Reducing Low Level Laser | Massager, Therapeutic, Manual |
| Classification Name: | Low level laser system for<br>aesthetic use | Therapeutic massager |
| Classification<br>Regulation: | 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

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

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

- 2. 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.
- 3. 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

- 17. 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 | Significant<br>Differences<br>Verju vs Cellulize | Significant<br>Differences<br>Photonica vs Cellulize |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Trade Name | Predicate<br>Verju Laser | Predicate<br>Photonica Professional | New Device<br>Cellulize | | |
| 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.<br>Indications for<br>Use | Device is indicated for use as<br>a non-invasive dermatological<br>aesthetic treatment as an<br>adjunct for individuals<br>intending to undergo<br>liposuction procedures for the<br>reduction of circumference of<br>hips, waist, and thighs. | Device is indicated for use as<br>a non-invasive dermatological<br>aesthetic treatment for the<br>reduction of circumference of<br>hips, waist, and thighs. | Cellulize is indicated for use as<br>a non-invasive dermatological<br>aesthetic treatment for the<br>reduction of circumference of<br>hips, waist, and thighs. | No difference except<br>that Verju indication<br>adds adjunct purpose<br>of preparing<br>individuals for<br>liposuction<br>procedures.<br>NOTE: Verju website<br>does not mention<br>adjunct purpose in<br>their marketing. | No Difference |
| 2.<br>Continuous or<br>Pulsed | Continuous | Continuous | Continuous | No Difference | No Difference |

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| Manufacturer<br>Trade Name | | Erchonia Corporation<br>Predicate<br>Verju Laser | Ward Photonics LLC<br>Predicate<br>Photonica Professional | Ward Photonics LLC | Significant<br>Differences<br>Verju vs Cellulize | Significant<br>Differences<br>Photonica vs Cellulize |
|----------------------------|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|------------------------------------------------------|
| | | | | New Device<br>Cellulize | | |
| 3. | Software Used? | Y – Verju has been marketed<br>in the United States with<br>various software operating<br>systems, including some that<br>incorporate pay-per-use<br>features. All versions provide<br>a 20-minute timer for the<br>front and then 20 minutes for<br>the back and operate using<br>touch screen buttons. | N – Photonica is controlled by<br>manual settings. | N – Cellulize is controlled by<br>manual settings. | Cellulize is simpler<br>without complex<br>software to track<br>usage and billing<br>functions. | No difference |
| 4. | Adjustable Light<br>Positioning? | Y – articulated arms allow for<br>many adjustments. | Y – articulated arm allows for<br>many adjustments. | Y – articulated arm allows for<br>many adjustments. | No Difference | No Difference |
| 5. | Non-invasive? | Y | Y | Y | No Difference | No Difference |
| | Safety Features | | | | | |
| 6. | Patient<br>Protective<br>Eyewear<br>Included? | N | Y – one box of 50 pairs of<br>Kentek IPL SmartShield<br>disposable eye protection are<br>included | Y – one box of 50 pairs of<br>Kentek IPL SmartShield<br>disposable eye protection are<br>included | Cellulize includes<br>patient protective<br>eyewear. | No Difference |
| 7. | Operator<br>Protective<br>Eyewear<br>Included? | Y – provides one pair of its<br>private label branded operator<br>protective eyewear | Y – one pair for the operator<br>(Kentek IPLSAFE) | Y – one pair for the operator<br>(Kentek IPLSAFE) | No Difference | No Difference |

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| | Manufacturer | Erchonia Corporation | Ward Photonics LLC | Ward Photonics LLC | Significant<br>Differences<br>Verju vs Cellulize | Significant<br>Differences<br>Photonica vs Cellulize |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| | Trade Name | | Predicate<br>Photonica Professional | New Device<br>Cellulize | | |
| 8. | Power protection | Unknown | Isolation transformer<br>separates facility power from<br>the device. Power switch that<br>cancels the treatment (lowest<br>risk; key switch not required<br>by IEEC standards). | Isolation transformer<br>separates facility power from<br>the device. Power switch that<br>cancels the treatment (lowest<br>risk; key switch not required<br>by IEEC standards). | Not available for<br>comparison. | No Difference |
| | Light Emissions Specifications | | | | | |
| 9. | Peak Wavelength | 532nm (visible green light<br>spectrum) | 635nm ±2nm (visible red light<br>spectrum) | 532nm ±3nm (visible green<br>light spectrum) | No Difference | Predicate Photonica<br>uses red light. |
| Manufacturer | Erchonia Corporation | Ward Photonics LLC | Ward Photonics LLC | Significant<br>Differences | Significant<br>Differences | |
| Trade Name | Predicate<br>Verju Laser | Predicate<br>Photonica Professional | New Device<br>Cellulize | Verju vs Cellulize | Photonica vs Cellulize | |
| 10. Total Power<br>Output | 102 mW Using (6) 17mW<br>Laser-Emitting Diodes (Lasers) | 240 W Using (150) 1600 mW<br>Light-Emitting Diodes (LEDs) | 240 W Using (150) 1600 mW<br>Light-Emitting Diodes (LEDs) | The cumulative total<br>power output of<br>Cellulize with 150 LEDs<br>is greater than the<br>cumulative power<br>output of Verju with<br>six lasers. | No Difference | |
| Manufacturer | Erchonia Corporation | Ward Photonics LLC | Ward Photonics LLC | Significant<br>Differences<br>Verju vs Cellulize | Significant<br>Differences<br>Photonica vs Cellulize | |
| Trade Name | Predicate<br>Verju Laser | Predicate<br>Photonica Professional | New Device<br>Cellulize | | | |
| 11. Outputintensity/<br>Irradiance<br>(mW/cm²) | 0.20 mW/cm² | 105 mW/cm² | 95.14 mW/cm² | The Verju delivers all<br>of its energy to a<br>single point on the skin<br>and uses scanning to<br>distribute the power.<br>At the point on the<br>skin where the laser is<br>focused, the laser is<br>more powerful than<br>the light from Cellulize,<br>but because the Verju<br>is continuously moving<br>the active pinpoint<br>with a scanning<br>motion, the total<br>photonic energy<br>(luminous flux)<br>delivered to the fat<br>cells is much lower<br>than Cellulize. | Essentially the same | |
| Manufacturer | Erchonia Corporation | Ward Photonics LLC | Ward Photonics LLC | Significant<br>Differences<br>Verju vs Cellulize | Significant<br>Differences<br>Photonica vs Cellulize | |
| Trade Name | Predicate<br>Verju Laser | Predicate<br>Photonica Professional | New Device<br>Cellulize | | | |
| 12. Standard<br>Treatment Time<br>(minutes) | Two 15-minute exposures<br>(front and back) at each 30-minute treatment session. The<br>standard protocol is three<br>sessions a week for two weeks<br>as determined by the doctor. | Four 8-minute exposures<br>(front, back, left, and right), 32-minute total per treatment<br>session. The standard protocol<br>is one session, taking the<br>"before" and "after"<br>measurements at the same<br>office visit. | A treatment regimen consists<br>of six sessions over a 2-week<br>period.<br>Each treatment is four 8-minute<br>exposures (front, back,<br>left, and right), 32-minute total<br>per treatment session. | Cellulize achieves inch-<br>loss results in one<br>regimen of six 32-min.<br>treatments.<br>Verju standard<br>protocol uses six 30-minute treatments to<br>achieve similar results | Cellulize achieves inch-<br>loss results in one<br>regimen of six 32-min.<br>treatments.<br>Photonica standard<br>protocol measures<br>treatment results after<br>single visit. | |
| 13. Maximum<br>Coverage Area<br>(cm²) | 516 cm² maximum total<br>coverage area with 6 scanning<br>lasers operating 8" from the<br>skin | 2294.0 cm² maximum total<br>coverage area with 150 LEDs<br>operating 6.8" from the skin | 2294.0 cm² maximum total<br>coverage area with 150 LEDs<br>operating 6.8" from the skin | Cellulize provides<br>uniform illumination<br>of 2294 cm² for the<br>entire treatment time.<br>Verju uses six laser<br>heads scanning areas<br>of 80 cm² for a total of<br>516 cm². | No difference | |
| Overall Device Specifications | | | | | | |
| 14. Unit Dimensions<br>(H x W x D) | 170.2 cm x 78.74 cm x 154.9<br>cm | 183.2 cm x 62.2 cm x 61 cm | 183.2 cm x 62.2 cm x 61 cm | Both are similarly<br>sized pole-mounted<br>mobile systems with<br>lights attached to<br>arms and four casters<br>for mobility. | No difference | |
| Manufacturer | Erchonia Corporation | Ward Photonics LLC | Ward Photonics LLC | Significant<br>Differences<br>Verju vs Cellulize | Significant<br>Differences<br>Photonica vs Cellulize | |
| Trade Name | Predicate<br>Verju Laser | Predicate<br>Photonica Professional | New Device<br>Cellulize | | | |
| 15. Weight (kg) | 32 kg | 52 kg (with carton) | 52 kg (with carton) | The Cellulize includes<br>the safety benefit of<br>an isolation<br>transformer that<br>alone weighs 7.7 kg.<br>It is unknown if the<br>weight of the<br>shipping carton is<br>included in the value<br>provided for the<br>predicate. | 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 up<br>to 41°C | +5°C to 35°C | +5°C to 35°C | Similar, both comply<br>with IEC 60601 safety<br>standard which<br>includes operating<br>temperatures and<br>humidity; intended<br>for use in same<br>environmental<br>conditions. | No difference | |
| 18. Operating Humidity | Unknown | 10% to 90% RH, non-<br>condensing | 10% to 90% RH, non-<br>condensing | No difference | No difference | |
| 19. Cooling<br>Mechanism | None | Forced air ventilation | Forced air ventilation | No functional<br>difference | No difference | |
| 20. Expected Use Life | Unknown expected useful life.<br>Comes with a two-year limited<br>warranty. | At least 8,700 hours<br>(16,312 of the 32-<br>minute treatment<br>sessions). Comes with<br>a two-year warranty. | At least 8,700 hours<br>(26,100 treatment<br>sessions). Comes with<br>a two-year warranty. | Similar. Both devices<br>come with a two-<br>year warranty. | No difference | |
| Manufacturer | Erchonia Corporation | Ward Photonics LLC | Ward Photonics LLC | Significant<br>Differences<br>Verju vs Cellulize | Significant<br>Differences<br>Photonica vs Cellulize | |
| Trade Name | Predicate<br>Verju Laser | Predicate<br>Photonica Professional | New Device<br>Cellulize | | | |
| 21. Meets the OLI<br>"Recognized<br>Consensus<br>Standard" | Yes | Yes | Yes | No difference | No difference | |
| Major Device Components | | | | | | |
| 22. Light Emitters | Verju has 532nm laser-<br>emitting diodes on<br>adjustable arms. | Cellulize has 635nm light-<br>emitting diodes on an<br>adjustable arm.…