(126 days)
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.
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.
The provided document is a 510(k) summary for the Resurgeonz PHantom Trilogy™ low-level laser system. It details the device's characteristics, intended use, and claims of substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or specific study data proving the device meets acceptance criteria in the way requested for an AI/ML medical device.
The questions provided in the prompt (acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance, training set details) are typically relevant for the regulatory review of Diagnostic AI/ML-enabled devices, particularly those that involve image analysis, disease detection, or treatment recommendations based on complex algorithms.
The PHantom Trilogy™ is described as a "low-level laser system for aesthetic use" for temporary reduction of circumference, operating via physical principles (laser light disrupting adipocyte cells). Its regulatory clearance is based on substantial equivalence to existing predicate devices, meaning it has similar technological characteristics and performs similarly in its intended use. This type of device's "performance data" typically refers to non-clinical (bench) tests to demonstrate its physical and electrical characteristics meet safety and performance standards, and potentially limited clinical data demonstrating the stated aesthetic effect, rather than the complex statistical validation required for AI/ML diagnostic tools.
Given the nature of this document and the device, I cannot fill in the requested table and answer the detailed questions relevant to an AI/ML device because that information is not present in this 510(k) summary. The document states:
- "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." (Page 3-4)
- "The Resurgeonz PHantom Trilogy™ meets the functional claims, and Intended Use as described in the product Labeling." (Page 5)
- "The safety and effectiveness are equivalent to the predicate device K192275 and predicate device K130341." (Page 5)
These statements indicate that the "study" proving the device meets acceptance criteria was primarily a comparison to predicate devices, supported by bench testing, rather than a clinical trial with the detailed statistical and ground truth methodologies typically found for AI/ML diagnostic tools.
Therefore, the requested information cannot be extracted from this document. If this were a submission for an AI/ML device, the detailed sections on performance, study design, and clinical data would be significantly different and much more extensive.
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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 CourtMerritt 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 CourtMerritt 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) towhich equivalence is claimed | The Resurgeonz, pHantom Trilogy™ has the followingsimilarities to the predicate device, IR Technology's invisa-RED ELITE (K192275) and Laser LipoLTD, Strawberry andStrawberry and Cream (K130341). |
| Reason for 510(k) | New device offering to the non-invasive aestheticenhancement market. |
| Device Description | The Resurgeonz pHantom Trilogy™ is a non-surgical, non-invasive, fat reducing low level laser system using acombination of Red and Infrared light spectrums topropagate laser frequencies of 660nm, 808nm and 980nminto a patient's dermal and adipose tissues for the reductionof the measured circumference of the patients waist, hips,and thighs. The device features an LCD touchscreen. Mode ofoperation is continuous. Allows individual patient sessioncontrols of: treatment time, energy, pulse and delay.Emergency safety cut off switch. Treatment applicators (multidiode paddles) connected to the device console can number8,10, or 12. Paddles include built in air fan cooling.Combination of Coherent Frequencies of red and infrared: 26diodes per big paddle, (13 red diodes at 660nm) and thirteen(13 infrared diodes) of the 13 infrared diodes, (6 diodes) are808nm and (7 diodes) are 980nm. Two smaller paddles areavailable to swap out in place of two big paddles. The twosmaller paddles only have 2 diodes each of red diodes at660nm and are used for smaller hard to reach body areas.Power output or each diode is variable up to 72mW to perdiode for all red and infrared diodes. The device does nothave wireless and/or external wired communication. Thedevice is powered by 120V, 60Hz. There is a side holder forpaddles when not in use. |
| Technological Characteristics | For comparison of technological characteristics with thepredicates please see the table below. |
| Performance Data | Resurgeonz pHantom TrilogyTM overall performance testingpassed all specified test requirements of non-clinical (bench)tests conducted for determination of Substantial Equivalence(SE) results, and show of Substantial Equivalence (SE) with thepredicate devices. |
| Indication for Use | Resurgeonz pHantom Trilogy™ is indicated for use as a non-surgical, non-invasive aesthetic treatment for the temporaryreduction of the circumference of waist, hips, thighs throughthe 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 CourtMerritt 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 | SubjectDeviceResurgeonz,LLCPHantom Trilogy™ | Predicate Device (K192275)IR Technologyinvisa-RED ELITE ™ | Predicate DeviceStrawberry/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™ isindicated for use as a non-surgical,non-invasive aesthetic treatment forthe temporary reduction of thecircumference of waist, hips, thighsthrough the process of disruptingadipocyte cells within the fat layer forthe release of fat and lipids from thetargeted cells. | The invisa-RED ™ is indicated for useas a non-invasive aesthetic treatmentfor the temporary reduction of thecircumference of waist, hips, thighsthrough the process ofphotobiomodulation affectingadipocyte cells within the adiposelayer for the release of lipids fromthese cells. | The Strawberry/Strawberry & Creamis indicated for use as a non-invasiveaesthetic treatment for thetemporary reduction in waistcircumference by the disruption ofadipocyte cells within the fat layer forthe release of fat and lipids fromthese cells. |
| Technology | Laser lights in the visible red andinfrared spectrums | Same | Laser lights in the visible redspectrum |
| Light Spectrum-Wavelength | Red light (Near Infrared) at 660nm andInfrared at 808nm and 980nm | Red light (Near Infrared) at 680nm andInfrared 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 LaserDiodes both 680nm and 980nm | 40 mW +/- 15% for each laser diode660 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 ofpaddles/probes(size small) | 2 (optional) with two 660nm diodesused to replace 2 big paddles | NA | 2 with one 660nm diode each,included with big paddles |
| Number of diodesper big paddle | 26 total, 13 red diodes and 13 infrareddiodes | Same | 6 red diodes per paddle |
| Number of diodesper small paddle | 2 total, 2 red diodes only 660NM | NA | Similar1 red diode per small paddle 660NM |
| Max number of NearInfrared diodes persystem (red) | 156 | Same | 62 |
| Max number ofInfrared diodes persystem | 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 Liquidingression | 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 ISO10993: Parts 1, 5, and 10 requirements | Same | similar |
| Sterility | Non sterile | Same | Same |
| EnvironmentalConditions for Use | Operating Temperature: 15.5°C ~26.6°COperating 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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§ 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.