Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the hardware (lasers, diodes, paddles, touchscreen) and basic operational controls (time, energy, pulse, delay). There is no mention of any software features that would suggest AI/ML, such as image analysis, automated parameter adjustments based on patient data, or predictive capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".

Therapeutic

Yes
The device is described as an "aesthetic treatment for the temporary reduction of the circumference of waist, hips, thighs through the process of disrupting adipocyte cells" which directly relates to modifying the body for an intended physical outcome. While "aesthetic," this function addresses a physical condition (excess circumference/fat) and aims to cause a physical change in the body, fitting the definition of a therapeutic device.

Diagnostic

No

The device is indicated for aesthetic treatment (temporary reduction of circumference) through fat cell disruption, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components such as a console, LCD touchscreen, treatment applicators (paddles) with diodes, and an emergency safety cut-off switch. It is a physical device that uses laser technology.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
Device Function: The Resurgeonz pHantom Trilogy™ is described as a non-surgical, non-invasive aesthetic treatment that uses low-level lasers applied externally to the body (waist, hips, thighs) to reduce circumference. It works by disrupting fat cells.
Lack of Sample Analysis: The device does not involve the collection or analysis of any biological samples from the patient. It directly interacts with the patient's body externally.

Therefore, the function and intended use of the Resurgeonz pHantom Trilogy™ fall outside the scope of In Vitro Diagnostics. It is a therapeutic/aesthetic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Resurgeonz pHantom Trilogy(TM) is indicated for use as a non-surgical, non-invasive aesthetic treatment for the temporary reduction of the circumference of waist, hips, thighs through the process of disrupting adipocyte cells, within the fat layer, for the release of fat and lipids from the targeted cells.

Product codes

OLI

Device Description

The Resurgeonz pHantom Trilogy™ is a non-surgical, non-invasive, fat reducing low level laser system using a combination of Red and Infrared light spectrums to propagate laser frequencies of 660nm, 808nm and 980nm into a patient's dermal and adipose tissues for the reduction of the measured circumference of the patients waist, hips, and thighs. The device features an LCD touchscreen. Mode of operation is continuous. Allows individual patient session controls of: treatment time, energy, pulse and delay. Emergency safety cut off switch. Treatment applicators (multi diode paddles) connected to the device console can number 8,10, or 12. Paddles include built in air fan cooling. Combination of Coherent Frequencies of red and infrared: 26 diodes per big paddle, (13 red diodes at 660nm) and thirteen (13 infrared diodes) of the 13 infrared diodes, (6 diodes) are 808nm and (7 diodes) are 980nm. Two smaller paddles are available to swap out in place of two big paddles. The two smaller paddles only have 2 diodes each of red diodes at 660nm and are used for smaller hard to reach body areas. Power output or each diode is variable up to 72mW to per diode for all red and infrared diodes. The device does not have wireless and/or external wired communication. The device is powered by 120V, 60Hz. There is a side holder for paddles when not in use.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

waist, hips, thighs

Indicated Patient Age Range

18 years old and over

Intended User / Care Setting

Healthcare provider office, Medi-Spas, and Clinics.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Resurgeonz pHantom TrilogyTM overall performance testing passed all specified test requirements of non-clinical (bench) tests conducted for determination of Substantial Equivalence (SE) results, and show of Substantial Equivalence (SE) with the predicate devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K192275, K130341

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 11, 2022

Resurgeonz LLC Julie Lalonde CEO 1550 Monte Carlo Court Merritt Island, Florida 32952

Re: K213534

Trade/Device Name: PHantom Trilogy(TM) Regulation Number: 21 CFR 878.5400 Regulation Name: Low Level Laser System For Aesthetic Use 878.5650 Regulatory Class: Class II Product Code: OLI Dated: January 20, 2022 Received: January 24, 2022

Dear Julie Lalonde:

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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213534

Device Name Resurgeonz pHantom Trilogy(TM)

Indications for Use (Describe)

Resurgeonz pHantom Trilogy(TM) is indicated for use as a non-surgical, non-invasive aesthetic treatment for the temporary reduction of the circumference of waist, hips, thighs through the process of disrupting adipocyte cells, within the fat layer, for the release of fat and lipids from the targeted cells.

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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510(k) SUMMARY

510(k) Summary of notification application K213534

Submitter Information
Submitted By:	Resurgeonz
Address	1550 Monte Carlo Court
Merritt Island, Florida 32952
Phone Number	321-222-5959
Fax Number	N/A
Establish Registration No.	622317
Are You a Small Business?	Yes - SBD22819
Name of Contact Person	Julie LaLonde
Contact Person Address	1550 Monte Carlo Court
Merritt Island, Florida 32952
Contact Person Phone No.	407-233-6292
Contact Person email	Admin@resurgeonz.com
Date Prepared	November 29, 2020
Name of Medical Device
Trade or proprietary name	pHantom Trilogy™
Common or usual name	Fat reducing Low Level Laser
Classification name	Fat reducing Low Level Laser system for aesthetic use
Classification panel	General & Plastic Surgery
Regulation	21 CFR 880.5440
Product Code(s)	OLI
Device Classification	II
Legally marketed device(s) to
which equivalence is claimed	The Resurgeonz, pHantom Trilogy™ has the following
similarities to the predicate device, IR Technology's invisa-
RED ELITE (K192275) and Laser LipoLTD, Strawberry and
Strawberry and Cream (K130341).
Reason for 510(k)	New device offering to the non-invasive aesthetic
enhancement market.
Device Description	The Resurgeonz pHantom Trilogy™ is a non-surgical, non-
invasive, fat reducing low level laser system using a
combination of Red and Infrared light spectrums to
propagate laser frequencies of 660nm, 808nm and 980nm
into a patient's dermal and adipose tissues for the reduction
of the measured circumference of the patients waist, hips,
and thighs. The device features an LCD touchscreen. Mode of
operation is continuous. Allows individual patient session
controls of: treatment time, energy, pulse and delay.
Emergency safety cut off switch. Treatment applicators (multi
diode paddles) connected to the device console can number
8,10, or 12. Paddles include built in air fan cooling.
Combination of Coherent Frequencies of red and infrared: 26
diodes per big paddle, (13 red diodes at 660nm) and thirteen
(13 infrared diodes) of the 13 infrared diodes, (6 diodes) are
808nm and (7 diodes) are 980nm. Two smaller paddles are
available to swap out in place of two big paddles. The two
smaller paddles only have 2 diodes each of red diodes at
660nm and are used for smaller hard to reach body areas.
Power output or each diode is variable up to 72mW to per
diode for all red and infrared diodes. The device does not
have wireless and/or external wired communication. The
device is powered by 120V, 60Hz. There is a side holder for
paddles when not in use.
Technological Characteristics	For comparison of technological characteristics with the
predicates please see the table below.
Performance Data	Resurgeonz pHantom TrilogyTM overall performance testing
passed all specified test requirements of non-clinical (bench)
tests conducted for determination of Substantial Equivalence
(SE) results, and show of Substantial Equivalence (SE) with the
predicate devices.
Indication for Use	Resurgeonz pHantom Trilogy™ is indicated for use as a non-
surgical, non-invasive aesthetic treatment for the temporary
reduction of the circumference of waist, hips, thighs through
the process of disrupting adipocyte cells, within the fat layer,
for the release of fat and lipids from the targeted cells.
Manufacturing Site	1550 Monte Carlo Court
Merritt Island, FL 32952
Environment for use	Healthcare provider office, Medi-Spas, and Clinics.
Single patient use	No
Sterilization process	N/A - The Resurgeonz PHantom Trilogy™ is supplied a non-sterile device. Cleaning instructions are provided in the User Manual.
Biocompatibility	Meets acceptance criteria per ISO 10993: Parts 1, 5, and 10 requirements
Conclusion on Substantial Equivalence	The Resurgeonz PHantom Trilogy™ described and comparatively analyzed in this submission is determined to be Substantially Equivalent (SE) to the predicate device, for intended use, design, component and materials, operating principles, environment for use, performance, safety, effectiveness, product labeling and packaging, and is supported by the information provided in the 510(k) submission.
Conclusions drawn from non-clinical and clinical data	The Resurgeonz PHantom Trilogy™ meets the functional claims, and Intended Use as described in the product Labeling.
Statement of Safety and Efficacy	The safety and effectiveness are equivalent to the predicate device K192275 and predicate device K130341. The claim for Substantial Equivalence (SE) is supported by the information provided in the 510(k) submission.

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| Characteristic | Subject
Device
Resurgeonz,
LLC
PHantom Trilogy™ | Predicate Device (K192275)
IR Technology
invisa-RED ELITE ™ | Predicate Device
Strawberry/Strawberry &
Cream (K130341) |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Class | II | II | II |
| Regulation Number | 21 CFR 878.5400 | 21 CFR 878.5400 | 21 CFR 878.5400 |
| Product Code(s) | OLI | OLI | OLI |
| Intended Use | Resurgeonz pHantom Trilogy™ is
indicated for use as a non-surgical,
non-invasive aesthetic treatment for
the temporary reduction of the
circumference of waist, hips, thighs
through the process of disrupting
adipocyte cells within the fat layer for
the release of fat and lipids from the
targeted cells. | The invisa-RED ™ is indicated for use
as a non-invasive aesthetic treatment
for the temporary reduction of the
circumference of waist, hips, thighs
through the process of
photobiomodulation affecting
adipocyte cells within the adipose
layer for the release of lipids from
these cells. | The Strawberry/Strawberry & Cream
is indicated for use as a non-invasive
aesthetic treatment for the
temporary reduction in waist
circumference by the disruption of
adipocyte cells within the fat layer for
the release of fat and lipids from
these cells. |
| Technology | Laser lights in the visible red and
infrared spectrums | Same | Laser lights in the visible red
spectrum |
| Light Spectrum-
Wavelength | Red light (Near Infrared) at 660nm and
Infrared at 808nm and 980nm | Red light (Near Infrared) at 680nm and
Infrared at 980nm | Red light (Near Infrared) 660 +/-
15nm |
| Light Waveform | Pulsed and Continuous | Same | Continuous |
| Laser Type | Diode Laser | Same | Same |
| Source Power | 120VAC / 60Hz | 120-240VAC / 50-60Hz | 100-240V, 50-60Hz |
| Light Power Output | 72mW each for Laser Diodes 660nm,
808nm and 980 nm | 200mW per diode each for Laser
Diodes both 680nm and 980nm | 40 mW +/- 15% for each laser diode
660 nm |
| Number of Pads /
Paddles | 6, 8, 10 or 12 Big Paddles (optional)
(size 130 x 66mm) | 6, 8, 10, or 12 Big Paddles (optional)
(size 130 x 66mm) | 4,6,8 or 10 Big paddles (optional)
(size similar) |
| Number of
paddles/probes
(size small) | 2 (optional) with two 660nm diodes
used to replace 2 big paddles | NA | 2 with one 660nm diode each,
included with big paddles |
| Number of diodes
per big paddle | 26 total, 13 red diodes and 13 infrared
diodes | Same | 6 red diodes per paddle |
| Number of diodes
per small paddle | 2 total, 2 red diodes only 660NM | NA | Similar
1 red diode per small paddle 660NM |
| Max number of Near
Infrared diodes per
system (red) | 156 | Same | 62 |
| Max number of
Infrared diodes per
system | 156 | Same | NA |
| Energy Delivery | Machine mounted paddles | Same | NA |
| Display | TFT Color Touchscreen LCD | Same | same |
| Console/Housing | ABS Plastic | Same | similar |
| Safety Features | Emergency stop button/key switch | same | same |
| Dust and Liquid
ingression | Rated IPXO | Not rated | Not rated |
| Paddle Cooling | Forced air cooled system | Same | NA |
| Target Population | 18 years old and over | Same | Same |
| Environment for use | Healthcare provider office,
MediSpas,and Clinics | Same | Same |
| Time of treatment | 10-20 minutes | 15-20 minutes | 10-20 minutes |
| Target body areas | Waist, hips, thighs | Same | waist |
| Biocompatibility | Meets acceptance criteria per ISO
10993: Parts 1, 5, and 10 requirements | Same | similar |
| Sterility | Non sterile | Same | Same |
| Environmental
Conditions for Use | Operating Temperature: 15.5°C ~
26.6°C
Operating Relative Humidity: ≤80% | Same | Same |
| Labeling | Product warnings and User Manual | Similar | Similar |
| Big Pad Dimension | 130mm x 66mm | 130mm x 66mm | 152.4mm x 50.8mm |
| Small Pad Dimension | 66mm x 45mm | N/A | 57.15mm x 50.8mm |
| Device Dimension | Approximately 44" x 18" x 14" | Approximately 38.6" x 18.5" x 19.68"
(98cm x 47cm x 50cm) | 12″ x 12″ x 13″ |
| Device Weight | Approximately 66.14 Ibs | 108 lbs | 13 lbs |

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