(226 days)
Not Found
No
The device description explicitly states "Cellulize does not use any software." and there are no mentions of AI, ML, or related concepts in the summary.
No.
The device is indicated for aesthetic treatments (reduction of circumference and temporary reduction of cellulite), which are typically not considered therapeutic as they do not treat a disease or medical condition.
No
The Cellulize® device is indicated for non-invasive dermatological aesthetic treatments (reduction of circumference and temporary reduction in the appearance of cellulite), not for diagnosing medical conditions.
No
The device description explicitly states "Cellulize does not use any software" and details multiple hardware components including LEDs, a controller console, an articulated arm, and a timer.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is a "non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs" and "temporary reduction in the appearance of cellulite." This describes a treatment applied to the body, not a test performed on samples taken from the body.
- Device Description: The description details a light-emitting system and a massager, both applied externally to the patient. There is no mention of analyzing biological samples.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis.
The device is clearly described as a therapeutic device for aesthetic purposes, not a diagnostic one.
N/A
Intended Use / Indications for 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.
Product codes
OLI, LYG
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hips, waist, thighs
Indicated Patient Age Range
18 years to 69 years old.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Study. Sample Size: 52 patients (25 Active Cellulize, 27 Placebo Control).
Key Results:
- 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.
- 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.
- 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) was used. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Mean Cumulative Inch Loss (calculated from "before"):
Cellulize Active Group: After 2.67, 7-day 3.40, 14-day 3.87
Placebo Group: After 0.52, 7-day 0.07, 14-day -0.82
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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/Proprietary
| Name: | CELLULIZE | Pure Wave Massager |
|---|---|---|
| Common/Usual Name: | Fat Reducing Low Level Laser | Massager, Therapeutic, Manual |
| Classification Name: | Low level laser system for | |
| aesthetic use | Therapeutic massager | |
| Classification | ||
| Regulation: | 878.5400 | 890.5660 |
| Product Code: | OLI | LYG |
| Device Class: | Class II | Class I |
| Classification Panel: | General & Plastic Surgery | Physical Medicine |
4
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.
5
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
6
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:
-
- 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.
7
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.
8
ATTACHMENT 1
Ward Photonics, LLC Traditional 510(k) Premarket Submission Cellulize
-
- 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.
-
- 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
-
- 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
9
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
Differences
Verju vs Cellulize | Significant
Differences
Photonica vs Cellulize |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Trade Name | Predicate
Verju Laser | Predicate
Photonica Professional | New Device
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.
Indications for
Use | Device is indicated for use as
a non-invasive dermatological
aesthetic treatment as an
adjunct for individuals
intending to undergo
liposuction procedures for the
reduction of circumference of
hips, waist, and thighs. | Device is indicated for use as
a non-invasive dermatological
aesthetic treatment for the
reduction of circumference of
hips, waist, and thighs. | Cellulize is indicated for use as
a non-invasive dermatological
aesthetic treatment for the
reduction of circumference of
hips, waist, and thighs. | No difference except
that Verju indication
adds adjunct purpose
of preparing
individuals for
liposuction
procedures.
NOTE: Verju website
does not mention
adjunct purpose in
their marketing. | No Difference |
| 2.
Continuous or
Pulsed | Continuous | Continuous | Continuous | No Difference | No Difference |
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| Manufacturer
Trade Name | | Erchonia Corporation
Predicate
Verju Laser | Ward Photonics LLC
Predicate
Photonica Professional | Ward Photonics LLC | Significant
Differences
Verju vs Cellulize | Significant
Differences
Photonica vs Cellulize |
|----------------------------|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|------------------------------------------------------|
| | | | | New Device
Cellulize | | |
| 3. | Software Used? | Y – Verju has been marketed
in the United States with
various software operating
systems, including some that
incorporate pay-per-use
features. All versions provide
a 20-minute timer for the
front and then 20 minutes for
the back and operate using
touch screen buttons. | N – Photonica is controlled by
manual settings. | N – Cellulize is controlled by
manual settings. | Cellulize is simpler
without complex
software to track
usage and billing
functions. | No difference |
| 4. | Adjustable Light
Positioning? | Y – articulated arms allow for
many adjustments. | Y – articulated arm allows for
many adjustments. | Y – articulated arm allows for
many adjustments. | No Difference | No Difference |
| 5. | Non-invasive? | Y | Y | Y | No Difference | No Difference |
| | Safety Features | | | | | |
| 6. | Patient
Protective
Eyewear
Included? | N | Y – one box of 50 pairs of
Kentek IPL SmartShield
disposable eye protection are
included | Y – one box of 50 pairs of
Kentek IPL SmartShield
disposable eye protection are
included | Cellulize includes
patient protective
eyewear. | No Difference |
| 7. | Operator
Protective
Eyewear
Included? | Y – provides one pair of its
private label branded operator
protective 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 | Significant
Differences
Verju vs Cellulize | Significant
Differences
Photonica vs Cellulize |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| | Trade Name | | Predicate
Photonica Professional | New Device
Cellulize | | |
| 8. | Power protection | Unknown | Isolation transformer
separates facility power from
the device. Power switch that
cancels the treatment (lowest
risk; key switch not required
by IEEC standards). | Isolation transformer
separates facility power from
the device. Power switch that
cancels the treatment (lowest
risk; key switch not required
by IEEC standards). | Not available for
comparison. | No Difference |
| | Light Emissions Specifications | | | | | |
| 9. | Peak Wavelength | 532nm (visible green light
spectrum) | 635nm ±2nm (visible red light
spectrum) | 532nm ±3nm (visible green
light spectrum) | No Difference | Predicate Photonica
uses red light. |
| Manufacturer | Erchonia Corporation | Ward Photonics LLC | Ward Photonics LLC | Significant
Differences | Significant
Differences | |
| Trade Name | Predicate
Verju Laser | Predicate
Photonica Professional | New Device
Cellulize | Verju vs Cellulize | Photonica vs Cellulize | |
| 10. Total Power
Output | 102 mW Using (6) 17mW
Laser-Emitting Diodes (Lasers) | 240 W Using (150) 1600 mW
Light-Emitting Diodes (LEDs) | 240 W Using (150) 1600 mW
Light-Emitting Diodes (LEDs) | The cumulative total
power output of
Cellulize with 150 LEDs
is greater than the
cumulative power
output of Verju with
six lasers. | No Difference | |
| Manufacturer | Erchonia Corporation | Ward Photonics LLC | Ward Photonics LLC | Significant
Differences
Verju vs Cellulize | Significant
Differences
Photonica vs Cellulize | |
| Trade Name | Predicate
Verju Laser | Predicate
Photonica Professional | New Device
Cellulize | | | |
| 11. Outputintensity/
Irradiance
(mW/cm²) | 0.20 mW/cm² | 105 mW/cm² | 95.14 mW/cm² | The Verju delivers all
of its energy to a
single point on the skin
and uses scanning to
distribute the power.
At the point on the
skin where the laser is
focused, the laser is
more powerful than
the light from Cellulize,
but because the Verju
is continuously moving
the active pinpoint
with a scanning
motion, the total
photonic energy
(luminous flux)
delivered to the fat
cells is much lower
than Cellulize. | Essentially the same | |
| Manufacturer | Erchonia Corporation | Ward Photonics LLC | Ward Photonics LLC | Significant
Differences
Verju vs Cellulize | Significant
Differences
Photonica vs Cellulize | |
| Trade Name | Predicate
Verju Laser | Predicate
Photonica Professional | New Device
Cellulize | | | |
| 12. Standard
Treatment Time
(minutes) | Two 15-minute exposures
(front and back) at each 30-minute treatment session. The
standard protocol is three
sessions a week for two weeks
as determined by the doctor. | Four 8-minute exposures
(front, back, left, and right), 32-minute total per treatment
session. The standard protocol
is one session, taking the
"before" and "after"
measurements at the same
office visit. | A treatment regimen consists
of six sessions over a 2-week
period.
Each treatment is four 8-minute
exposures (front, back,
left, and right), 32-minute total
per treatment session. | Cellulize achieves inch-
loss results in one
regimen of six 32-min.
treatments.
Verju standard
protocol uses six 30-minute treatments to
achieve similar results | Cellulize achieves inch-
loss results in one
regimen of six 32-min.
treatments.
Photonica standard
protocol measures
treatment results after
single visit. | |
| 13. Maximum
Coverage Area
(cm²) | 516 cm² maximum total
coverage area with 6 scanning
lasers operating 8" from the
skin | 2294.0 cm² maximum total
coverage area with 150 LEDs
operating 6.8" from the skin | 2294.0 cm² maximum total
coverage area with 150 LEDs
operating 6.8" from the skin | Cellulize provides
uniform illumination
of 2294 cm² for the
entire treatment time.
Verju uses six laser
heads scanning areas
of 80 cm² for a total of
516 cm². | No difference | |
| Overall Device Specifications | | | | | | |
| 14. Unit Dimensions
(H x W x D) | 170.2 cm x 78.74 cm x 154.9
cm | 183.2 cm x 62.2 cm x 61 cm | 183.2 cm x 62.2 cm x 61 cm | Both are similarly
sized pole-mounted
mobile systems with
lights attached to
arms and four casters
for mobility. | No difference | |
| Manufacturer | Erchonia Corporation | Ward Photonics LLC | Ward Photonics LLC | Significant
Differences
Verju vs Cellulize | Significant
Differences
Photonica vs Cellulize | |
| Trade Name | Predicate
Verju Laser | Predicate
Photonica Professional | New Device
Cellulize | | | |
| 15. Weight (kg) | 32 kg | 52 kg (with carton) | 52 kg (with carton) | The Cellulize includes
the safety benefit of
an isolation
transformer that
alone weighs 7.7 kg.
It is unknown if the
weight of the
shipping carton is
included in the value
provided for the
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
to 41°C | +5°C to 35°C | +5°C to 35°C | Similar, both comply
with IEC 60601 safety
standard which
includes operating
temperatures and
humidity; intended
for use in same
environmental
conditions. | No difference | |
| 18. Operating Humidity | Unknown | 10% to 90% RH, non-
condensing | 10% to 90% RH, non-
condensing | No difference | No difference | |
| 19. Cooling
Mechanism | None | Forced air ventilation | Forced air ventilation | No functional
difference | No difference | |
| 20. Expected Use Life | Unknown expected useful life.
Comes with a two-year limited
warranty. | At least 8,700 hours
(16,312 of the 32-
minute treatment
sessions). Comes with
a two-year warranty. | At least 8,700 hours
(26,100 treatment
sessions). Comes with
a two-year warranty. | Similar. Both devices
come with a two-
year warranty. | No difference | |
| Manufacturer | Erchonia Corporation | Ward Photonics LLC | Ward Photonics LLC | Significant
Differences
Verju vs Cellulize | Significant
Differences
Photonica vs Cellulize | |
| Trade Name | Predicate
Verju Laser | Predicate
Photonica Professional | New Device
Cellulize | | | |
| 21. Meets the OLI
"Recognized
Consensus
Standard" | Yes | Yes | Yes | No difference | No difference | |
| Major Device Components | | | | | | |
| 22. Light Emitters | Verju has 532nm laser-
emitting diodes on
adjustable arms. | Cellulize has 635nm light-
emitting diodes on an
adjustable arm. | Cellulize has 532nm light-
emitting diodes on an
adjustable arm. | No difference | LEDs are red 635nm
instead of 532nm | |
| 23. Base Unit | Contains the Control Unit:
• LCD Display
• Keyboard for user input
• Control electronics
• Power supply with an
interchangeable fuse | Contains the Control Console:
• Power indicator lamp
• Start button
• Timer switch
• Output connector to the
LED Panel
• Power entry module with
two user replaceable
fuses
• Hours meter. | Contains the Control Console:
• Power indicator lamp
• Start button
• Timer switch
• Output connector to the
LED Panel
• Power entry module with
two user replaceable
fuses
• Hours meter. | The predicate device
is softwaredriven
and allows the user
to select which lasers
are active. Also used
to track usage
minutes and charge
users according to
Verju fee structure.
The Cellulize uses
mechanical timers. | No difference | |
| 24. Mobile Cart | Y- mobile cart
mounted system. | Y- mobile cart
mounted system. | Y- mobile cart
mounted system. | No difference | No difference | |
| 25. Arms | Y - A folding arm system
attaches the control unit to
the laser heads. | Y - A fully articulating arm
attaches to the mobile pole
cart and the LED Panel. | Y - A fully articulating arm
attaches to the mobile pole
cart and the LED Panel. | Essentially no
difference | No difference | |
| Manufacturer | Erchonia Corporation | Ward Photonics LLC | Ward Photonics LLC | Significant
Differences
Verju vs Cellulize | Significant
Differences
Photonica vs Cellulize | |
| Trade Name | Predicate
Verju Laser | Predicate
Photonica Professional | New Device
Cellulize | | | |
| 26. Isolation
Transformer | Unknown | Y - A hospital-approved
isolation transformer to
provide additional protection
to the patient from touch
voltage -- reducing the
maximum touch voltage by
94%, from 0.8v to 0.046v. | Y - A hospital-approved
isolation transformer to
provide additional protection
to the patient from touch
voltage -- reducing the
maximum touch voltage by
94%, from 0.8v to 0.046v. | Unable to determine | No difference | |
13
14
15
16
17
18
Substantial Equivalence Discussion
19
Table 7-3 – Comparison to legally marketed predicate massager device (ref: Section 13, Substantial Equivalence).
| Manufacturer | | Erchonia Corporation | Pado, Inc. | Significant
Differences
Percussor vs PureWave |
|---------------------------------|--------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Address | | 650 Atlantis Rd
Melbourne, FL 32904 | 28340 Avenue Crocker Unit 100
Valencia, CA 91355 | |
| Trade Name | | Predicate
Percussor Therapeutic Massager | New Device
PureWave CM5 | |
| 510(k) Number | | K130922 | N/A | No Difference. PureWave is Class
exempt device. Percussor was
included in K130922 as a Class I
companion device. |
| Product code | | LYG / ISA | LYG / ISA | |
| Regulation Number | | 890.5660 | 890.5660 | |
| 1. | Indications for
Use | The Massager component is indicated for the
temporary reduction in the appearance of cellulite. | The Massager component is indicated for the
temporary reduction in the appearance of cellulite. | No Difference |
| 2. | Claims / Clinical
Efficacy | 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 Speed
Range | 1 rpm - 3,600 rpm | 1,500 rpm - 3,700 rpm | Essentially No Difference |
| Manufacturer | Erchonia Corporation | Pado, Inc. | Significant
Differences
Percussor vs PureWave | |
| Address | 650 Atlantis Rd
Melbourne, FL 32904 | 28340 Avenue Crocker Unit 100
Valencia, CA 91355 | | |
| Trade Name | Predicate
Percussor Therapeutic Massager | New Device
PureWave 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 slight
exceeds Percussor. | |
| 9. Charger Input
Voltage | 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 Output
Voltage | 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. Multiple
Attachment Tips | Two Tips: One cone head tip, and one flat pad tip.
NOTE: optional attachments available, not
included. | Three Tips: One cone head tip, one six-point tip,
and one flat pad tip. | PureWave includes an additional
style of tip for more functionality. | |
| 14. Hand-held | YES | YES | No difference | |
| 15. Software | NO | NO | No difference | |
| Manufacturer | Erchonia Corporation | Pado, Inc. | Significant
Differences
Percussor vs PureWave | |
| Address | 650 Atlantis Rd
Melbourne, FL 32904 | 28340 Avenue Crocker Unit 100
Valencia, CA 91355 | | |
| Trade Name | Predicate
Percussor Therapeutic Massager | New Device
PureWave CM5 | | |
| 16. General Controls | YES | YES | No difference | |
20
21
22
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.