Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension Kit 1 (UL-800-Shape-Ext-Kit-1);Ultimate Shape Extension Kit 2 (UL-800-Shape-Ext-Kit-2)
Device Facts
| Record ID | K260945 |
|---|---|
| Device Name | Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension Kit 1 (UL-800-Shape-Ext-Kit-1);Ultimate Shape Extension Kit 2 (UL-800-Shape-Ext-Kit-2) |
| Applicant | Fit-Pro KFT (Ltd.) - DBA E-Fit |
| Product Code | NGX · Physical Medicine |
| Decision Date | Sep 27, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5850 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The ULTIMA UL-800 System is intended for use in adults 22 years of age and older. The system is designated for for prescription use only in professional healthcare settings. The ULTIMA UL-800 System provides two energy modalities, electrical stimulation and light output. Electrical stimulation has separate body NGX and facial NFO applications. Electrical stimulation and light output are operated separately and cannot be delivered simultaneously. NGX electrical muscle stimulation function The ULTIMA UL-800 System is intended to apply electrical current through surface electrodes to healthy muscles for muscle-conditioning purposes by temporarily affecting the stimulated muscle's contractile properties, force output, and/or fatigue resistance. The NGX function is not intended for rehabilitation or for the treatment of patients with medical conditions. NGX is available with UL-PAD-IR1 / IR2 / IR3 / IR4 for the labeled body parts. NFO facial aesthetic electrical stimulation function When UL-FACE is operated in the separate NFO electrical stimulation mode, the ULTIMA UL-800 System is indicated for aesthetic use including facial skin stimulation. Application is limited to the labeled forehead and cheek sites on intact skin. This function is not intended for rehabilitation, treatment of medical conditions, or conditioning of facial muscles to improve contractile properties, force output, or fatigue resistance. ILY topical-heating light function When UL-FACE is operated in the separate ILY light mode, the ULTIMA UL-800 System is intended to emit energy in the visible red and near-infrared spectrum to provide topical heating for the purpose of elevating tissue temperature, temporarily increasing local blood circulation, and temporarily relaxing muscles.
Device Story
Ultima System (UL-800) is a microprocessor-controlled, externally powered device for professional healthcare use; features 15-inch touchscreen and rotary encoder. Inputs: user-selected programs via GUI. Outputs: electrical muscle stimulation (EMS) via UL-PAD applicators for body; facial aesthetic electrical stimulation (TENS) via UL-FACE; or infrared light for topical heating. Modalities operate independently; cannot be delivered simultaneously. System mounted on mobile stand. Healthcare providers manage settings and programs; output affects muscle contractile properties or provides thermal effects. Benefits include muscle conditioning, aesthetic facial stimulation, and temporary muscle relaxation/increased circulation. Safety features include hardware-based health protection, relay isolation, DC blocking, and software-based watchdog/no-load detection.
Clinical Evidence
Bench testing only. Includes biocompatibility (per 2023 FDA guidance), shelf-life (ASTM F1980-21), software validation (IEC 62304), cybersecurity, electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), photobiological safety (IEC 62471), and performance testing per FDA Powered Muscle Stimulator guidance.
Technological Characteristics
Microprocessor-controlled; 15-inch TFT LCD touchscreen; 24V DC power. Electrodes: 316L stainless steel. Waveform: charge-balanced biphasic rectangular modulated by trapezoidal. Connectivity: standalone. Sterilization: N/A (reusable components). Standards: IEC 60601-1, IEC 60601-2-10, IEC 60601-2-57, IEC 62471.
Indications for Use
Indicated for adults 22+ in professional healthcare settings for muscle conditioning (body), aesthetic facial skin stimulation, and topical heating (red/NIR light). Contraindicated for rehabilitation or treatment of medical conditions.
Regulatory Classification
Identification
A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.
Predicate Devices
- E-Fit Infinity System (K202148)
- BTL-785BNF-E (K242532)
- Dermalux Flex MD (K212275)
- LightStim for Pain LED Belt (K15133)
Submission Summary (Full Text)
{1}
**U.S. FOOD & DRUG**
ADMINISTRATION
September 27, 2026
Fit-Pro KFT (Ltd.) - DBA E-Fit
% Tom Cronin
Official Correspondent
Medical Device Academy, Inc.
345 Lincoln Hill Rd.
Shrewsbury, Vermont 05738
Re: K260945
Trade/Device Name: Ultima System (UL-800); Ultimate Face Package (UL-800-Face-Set); Ultimate Shape Extension Kit 1 (UL-800-Shape-Ext-Kit-1); Ultimate Shape Extension Kit 2 (UL-800-Shape-Ext-Kit-2)
Regulation Number: 21 CFR 890.5850
Regulation Name: Powered muscle stimulator
Regulatory Class: Class II
Product Code: NGX, NFO, ILY
Dated: August 28, 2026
Received: August 28, 2026
Dear Tom Cronin:
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 (the 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 available 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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K260945 - Tom Cronin
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K260945 - Tom Cronin
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assistance/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,
# Heather L. Dean -S
Heather Dean, PhD
Assistant Director
DHT5B: Division of Neuromodulation and
Physical Medicine Devices
OHT5: Office of Neurological and
Physical Medicine Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K260945 | ? |
| Please provide the device trade name(s). | | ? |
| Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension Kit 1 (UL-800-Shape-Ext-Kit-1);Ultimate Shape Extension Kit 2 (UL-800-Shape-Ext-Kit-2) | | |
| Please provide your Indications for Use below. | | ? |
| The ULTIMA UL-800 System is intended for use in adults 22 years of age and older. The system is designated for for prescription use only in professional healthcare settings.The ULTIMA UL-800 System provides two energy modalities, electrical stimulation and light output.Electrical stimulation has separate body NGX and facial NFO applications. Electrical stimulation and light output are operated separately and cannot be delivered simultaneously.NGX electrical muscle stimulation functionThe ULTIMA UL-800 System is intended to apply electrical current through surface electrodes to healthy muscles for muscle-conditioning purposes by temporarily affecting the stimulated muscle's contractile properties, force output, and/or fatigue resistance. The NGX function is not intended for rehabilitation or for the treatment of patients with medical conditions. NGX is available with UL-PAD-IR1 / IR2 / IR3 / IR4 for the labeled body parts.NFO facial aesthetic electrical stimulation functionWhen UL-FACE is operated in the separate NFO electrical stimulation mode, the ULTIMA UL-800 System is indicated for aesthetic use including facial skin stimulation. Application is limited to the labeled forehead and cheek sites on intact skin. This function is not intended for rehabilitation, treatment of medical conditions, or conditioning of facial muscles to improve contractile properties, force output, or fatigue resistance.ILY topical-heating light functionWhen UL-FACE is operated in the separate ILY light mode, the ULTIMA UL-800 System is intended to emit energy in the visible red and near-infrared spectrum to provide topical heating for the purpose of elevating tissue temperature, temporarily increasing local blood circulation, and temporarily relaxing muscles. | | |
| Please select the types of uses (select one or both, as applicable). | Prescription Use (21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
| Please select the age group(s) for which the device(s) is to be used. | Neonates/Newborns (Birth to < 29 days old)Infants (29 days old to < 2 years old)Children (2 years old to < 12 years old)Adolescents (12 years old to < 22 years old)Adults (22 years old and greater) | ? |
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510(k) #: k260945
# 510(k) Summary
Prepared on: 2026-09-26
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | Fit-Pro KFT (Ltd.) - DBA E-Fit |
| --- | --- |
| Applicant Address | Szabadság Ter 7 Budapest 1054 Hungary |
| Applicant Contact Telephone | +36-304772460 |
| Applicant Contact | Dr. Janos Papp |
| Applicant Contact Email | janospapp@e-fit.com |
| Correspondent Name | Medical Device Academy, Inc. |
| Correspondent Address | 345 Lincoln Hill Road Shrewsbury VT 05738 United States |
| Correspondent Contact Telephone | +1.631.935.3173 |
| Correspondent Contact | Mr. Tom Cronin |
| Correspondent Contact Email | tom@fdaestar.com |
Device Name
21 CFR 807.92(a)(2)
| Device Trade Name | Ultima System (UL-800); Ultimate Face Package (UL-800-Face-Set); Ultimate Shape Extension Kit 1 (UL-800-Shape-Ext-Kit-1); Ultimate Shape Extension Kit 2 (UL-800-Shape-Ext-Kit-2) |
| --- | --- |
| Common Name | Powered muscle stimulator |
| Classification Name | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Regulation Number | 890.5850 |
| Product Code(s) | NGX, NFO, ILY |
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| --- | --- | --- |
| K202148 | E-Fit Infinity System | NGX |
| K242532 | BTL-785BNF-E | NFO |
| K212275 | Dermalux Flex MD | ILY |
| K15133 | LightStim for Pain LED Belt | ILY |
Device Description Summary
21 CFR 807.92(a)(4)
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The ULTIMA UL-800 System is an externally powered, microprocessor-controlled medical electrical system. The controller includes a 15-inch TFT LCD touchscreen, rotary encoder, treatment-output electronics, safety monitoring, and manufacturer-installed software. The System separately provides electrical stimulation or infrared light output separately. UL-PAD applicators deliver electrical muscle stimulation (EMS) to labeled body locations. The UL-FACE delivers facial aesthetic transcutaneous electrical nerve stimulation (TENS) or the separate infrared topical-heating light function. The controls adjust output delivery. The ULTIMA System is mounted on a movable stand with four wheels.
## Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The ULTIMA UL-800 System is intended for use in adults 22 years of age and older. The system is designated for for prescription use only in professional healthcare settings.
The ULTIMA UL-800 System provides two energy modalities, electrical stimulation and light output. Electrical stimulation has separate body NGX and facial NFO applications. Electrical stimulation and light output are operated separately and cannot be delivered simultaneously.
NGX electrical muscle stimulation function
The ULTIMA UL-800 System is intended to apply electrical current through surface electrodes to healthy muscles for muscle-conditioning purposes by temporarily affecting the stimulated muscle's contractile properties, force output, and/or fatigue resistance. The NGX function is not intended for rehabilitation or for the treatment of patients with medical conditions. NGX is available with UL-PAD-IR1 / IR2 / IR3 / IR4 for the labeled body parts.
NFO facial aesthetic electrical stimulation function
When UL-FACE is operated in the separate NFO electrical stimulation mode, the ULTIMA UL-800 System is indicated for aesthetic use including facial skin stimulation. Application is limited to the labeled forehead and cheek sites on intact skin. This function is not intended for rehabilitation, treatment of medical conditions, or conditioning of facial muscles to improve contractile properties, force output, or fatigue resistance.
ILY topical-heating light function
When UL-FACE is operated in the separate ILY light mode, the ULTIMA UL-800 System is intended to emit energy in the visible red and near-infrared spectrum to provide topical heating for the purpose of elevating tissue temperature, temporarily increasing local blood circulation, and temporarily relaxing muscles.
## Indications for Use Comparison
21 CFR 807.92(a)(5)
The ULTIMA UL-800 NGX body function is compared with E-Fit Infinity System (K202148) for stimulation and conditioning of healthy body muscles. The primary predicate's muscle-conditioning scope is not extended to the face.
The NFO facial function is compared directly with BTL-785BNF-E K242532 for aesthetic facial skin stimulation. ULTIMA retains a narrower anatomical scope. The shared electrical-stimulation principle and biphasic waveform support the comparison. Pulse timing, charge, applicator geometry and contact materials are explicitly evaluated as differences rather than represented as identical.
The ILY topical-heating function is compared with Dermalux Flex MD K212275 and LightStim for Pain LED Belt K15133 for tissue heating, temporary local circulation increase and temporary muscle relaxation. Their additional acne, wrinkle and pain claims are not adopted for ULTIMA.
Technological Comparison
21 CFR 807.92(a)(6)
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| Device & Predicate Device(s): | K260945 | K202148 | K242532 |
| --- | --- | --- | --- |
| General Device Characteristics | Subject Device | Primary Predicate | Secondary Predicate |
| NGX/NFO Electrical Stimulation | | | |
| Trade Name | Ultima System (ULTIMA UL-800) | E-Fit Infinity System (EF-100, EF-2090) | BTL-785BNF-E |
| Manufacturer | Fit-Pro KFT, Ltd. | Fit-Pro Ltd. | BTL Industries, Inc. |
| Reg. Name | Powered muscle stimulator, for muscle conditioning; Infrared therapeutic heating lamp | Powered muscle stimulator, for muscle conditioning | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Pro. Code | NGX, NFO, ILY | NGX | NFO |
| Reg. Number | 890.5850, 882.5890, 890.5500 | 890.5850 | 882.5890 |
| Class | II | II | II |
| Intended Use | The ULTIMA UL-800 System is intended for use in adults 22 years of age and older. The system is designated for for prescription use only in professional healthcare settings. The ULTIMA UL-800 System provides two energy modalities, electrical stimulation and light output. Electrical stimulation has separate body NGX and facial NFO applications. Electrical stimulation and light output are operated separately and cannot be delivered simultaneously. NGX electrical muscle stimulation function The ULTIMA UL-800 System is intended to apply electrical current through surface electrodes to healthy muscles for muscle-conditioning purposes by temporarily affecting the stimulated muscle's contractile properties, force output, and/or fatigue resistance. The NGX function is not intended for rehabilitation or for the treatment of patients with medical conditions. NGX is available with UL-PAD-IR1 / IR2 / IR3 / IR4 for the labeled body parts. NFO facial aesthetic electrical stimulation function When UL-FACE is operated in the separate NFO electrical stimulation mode, the ULTIMA UL-800 System is indicated for aesthetic use including facial skin stimulation. Application is limited to the labeled forehead and cheek sites on intact skin. This function is not intended for rehabilitation, treatment of medical conditions, or conditioning of facial muscles to improve contractile properties, force output, or fatigue resistance. ILY topical-heating light function | E-Fit Infinity System (EF-2090 and EF-100) is a machine system with electronic muscle stimulation based on EMS technology. Regarding its use, the output power is limited and specifically designed as an addition to other sports and for toning muscles. It may only be used for healthy muscles and clients, and not to be used for rehabilitation purposes. The E-Fit Infinity system was designed to stimulate healthy muscles in order to improve or facilitate muscle performance. The E-Fit Infinity system must not be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the E Fit Infinity system training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. The E-Fit Infinity system's electrical impulses allow the triggering of action potentials on motoneurons of motor nerves (excitations). These excitations of motoneurons are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles. The various types of muscle work that the E-Fit Infinity system can impose on the stimulated muscles are able to improve or facilitate muscle performance. The E-Fit Infinity system may therefore be considered a technique of muscle training. | The device is indicated for aesthetic use including facial and neck or body skin stimulation. |
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| Device & Predicate Device(s): | K260945 | K202148 | K242532 |
| --- | --- | --- | --- |
| General Device Characteristics | Subject Device | Primary Predicate | Secondary Predicate |
| NGX/NFO Electrical Stimulation | | | |
| Trade Name | Ultima System (ULTIMA UL-800) | E-Fit Infinity System (EF-100, EF-2090) | BTL-785BNF-E |
| | When UL-FACE is operated in the separate ILY light mode, the ULTIMA UL-800 System is intended to emit energy in the visible red and near-infrared spectrum to provide topical heating for the purpose of elevating tissue temperature, temporarily increasing local blood circulation, and temporarily relaxing muscles. | | |
| Intended Users | Trained Healthcare Professionals | Trained Healthcare Professionals | Trained Healthcare Professionals |
| Use Environment | Professional Healthcare Facility | Professional Healthcare Facility | Prescription Use Setting |
| User Interface | The UL-800-ULTIMA Controller device is equipped with 15" multi touch screen and a rotary encoder. When the device is turned on the Graphical User Interface (GUI) appears on the screen. The Controller is designed to control the UL-FACE (TENS) and UL-PAD-IR (EMS) applicators. Every channel assigned to separate muscle groups can be controlled with corresponding buttons on the touchscreen display. The operating interface is used to manage the different programs and settings. | The wireless controller has rotary encoder which allows for a quick set-up, and because of the push button capability, the program can be stopped immediately for every channel. There are large START/STOP and POWER off buttons to begin the program and for complete power shutdown. Because of the pictographs on the displays and fixed electrodes in the clothing, it is very easy to set the appropriate muscle groups. | Main control unit with touchscreen controller. Stimulation is provided by a handpiece with single-use application electrodes connected via cables to the main console. |
| Prescription | Prescription | Prescription | Prescription |
| Power Source | External AC/DC Power supply; 24 V DC; 220 W | Battery 3.7 V Lithium Polymer (x2) | Mains Power, 100-240 V, 50 – 60 Hz |
| Treatment Time | 30 min | 30 min | Up to 20 min |
| Output Modes | Two Electrical (EMS, TENS); Infrared Light Stimulation provided independent of each other. | One EMS | One TENS |
| Auto-shutoff | Startup self-test, current/voltage limits, no-load/contact detection, watchdog, hardware Health Protection/relay isolation, DC blocking, safe OFF on stop/fault/reset/interruption, and no automatic restart. | Self-test, short-circuit and no-/on-load monitoring, watchdog, battery/current monitoring, emergency stop, and hardware-error monitoring. | Patient discomfort shut-off button |
| Electrode Materials | 316L Stainless Steel | 316L Stainless Steel | Conductive Silver ink |
| Patient Electrode Interface | Reusable stainless-steel electrode through patient-assigned UL-UC textile (96% cotton / 4% elastane), uniformly moistened only with potable water. | Electrode through 100% hygroscopic cotton moistened with tap water; no direct electrode-to-skin placement. | Electrode via electroconductive hydrogel. |
| Anatomical Location of Stimulation | Face (TENS): 1. M. Frontalis 2. M. Buccinator 3. M. Masseter | 1. Chest 2. Arms 3. Abdominals 4. Back | Face, neck and body |
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| Device & Predicate Device(s): | K260945 | K202148 | K242532 |
| --- | --- | --- | --- |
| General Device Characteristics | Subject Device | Primary Predicate | Secondary Predicate |
| NGX/NFO Electrical Stimulation | | | |
| Trade Name | Ultima System (ULTIMA UL-800) | E-Fit Infinity System (EF-100, EF-2090) | BTL-785BNF-E |
| | Body (EMS): 1. Abdominis 2. Rectus Femoris 3. Vastus Medialis 4. Vastus Lateralis 5. Gluteus Maximus 6. Musculi Ischiocrurales | 5. Thighs 6. Buttocks 7. Glutes 8. Hamstrings 9. Calves | |
| Reusable | Yes | Yes | No, Single Use electrodes |
| Electrode Size (cm2) | Face: 45.21 (aggregate); Body: 114.7 (per applicator) | Not available. | 1: 3.8 cm² 2: 4.0 cm² 7: 1.9 cm² 8: 2.9 cm² 9: 3.5 cm² 11: 1.8 cm² |
| Number of Channels | 1 output channel, Time-separated switching to 11 outputs/channels; and electrical current can be regulated individually on every output. | 1 output channel can shift in time between the 12 outputs and electrical current can be regulated individually on every output. | Not publicly available |
| Max Output Current (@ 500 Ω) | 75 mA | 75 mA | G1: 97 mA G2: 64 mA G3: 30 mA |
| Max Output Voltage (@ 500 Ω) | 37.5 V | 37.2 V | 48.5 V |
| Max Phase Charge μC (@ 500 Ω) | Face: 13; Body: 24 | 26 | G1: 15 μC G2: 10 μC G3: 5 μC |
| Max Current Density (mA/cm2) (@ 500 Ω) | 0.6538 | 0.9365 | 1: 16.8; 2: 24.3; 7: 33.7; 8: 33.5; 9: 27.7 11: 16.4 mA/cm² Not identified as RMS. |
| Max Power Density (W/cm2) (@ 500 Ω) | 0.0306 | 0.0342 | 1: 0.033; 2: 0.047; 7: 0.065; 8: 0.065; 9: 0.054; 11: 0.032 |
| Waveform | Charge-balanced biphasic rectangular pulse modulated by trapezoidal | Symmetric biphasic | Charge-balanced biphasic rectangular pulse modulated by trapezoidal |
| Frequency (Hz) | 4 - 220 | 4 - 90 | 250 |
| Pulse Duration | 100 - 500 μs | 100 - 500 μs | 160 μs |
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| Device & Predicate Device(s): | K260945 | K212275 | K15133 |
| --- | --- | --- | --- |
| General Device Characteristics | Subject Device | Secondary Predicate | Secondary Predicate |
| ILY Photostimulation | | | |
| Trade Name | Ultima System (UL-800-ULTIMA) | Dermalux Flex MD | LightStim for Pain |
| Manufacturer | Fit-Pro KFT, Ltd. | Aesthetic Technology, Ltd. | LED Intellectual Properties LLC |
| Reg. Name | Powered muscle stimulator, for muscle conditioning; Infrared therapeutic heating lamp | Laser Surgical Instrument for Use in General and Plastic Surgery in Dermatology | Infrared therapeutic heating lamp |
| Pro. Code | NGX, NFO, ILY | OLP, OHS, ILY | ILY |
| Reg. Number | 890.5850, 882.5890, 890.5500 | 878.4810, 890.5500 | 890.5500 |
| Class | II | II | II |
| Intended Use | The ULTIMA UL-800 System is intended for use in adults 22 years of age and older. The system is designated for prescription use only in professional healthcare settings. The ULTIMA UL-800 System provides two energy modalities, electrical stimulation and light output. Electrical stimulation has separate body NGX and facial NFO applications. Electrical stimulation and light output are operated separately and cannot be delivered simultaneously. NGX electrical muscle stimulation function The ULTIMA UL-800 System is intended to apply electrical current through surface electrodes to healthy muscles for muscle-conditioning purposes by temporarily affecting the stimulated muscle's contractile properties, force output, and/or fatigue resistance. The NGX function is not intended for rehabilitation or for the treatment of patients with medical conditions. NGX is available with UL-PAD-IR1 / IR2 / IR3 / IR4 for the labeled body parts. NFO facial aesthetic electrical stimulation function When UL-FACE is operated in the separate NFO electrical stimulation mode, the ULTIMA UL-800 System is indicated for aesthetic use including facial skin stimulation. Application is limited to the labeled forehead and cheek sites on intact skin. This function is not intended for rehabilitation, treatment of medical conditions, or conditioning of facial muscles to improve contractile properties, force output, or fatigue resistance. ILY topical-heating light function When UL-FACE is operated in the | Intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. The blue spectrum light is intended to reduce mild to moderate inflammatory acne vulgaris. Intended to emit energy in the red and infrared spectrum for use in dermatology for the treatment of periorbital and full face wrinkles. | The LightStim for Pain LED Belt is an Over-The-Counter device intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and the temporary relaxation of muscles. |
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| Device & Predicate Device(s): | K260945 | K212275 | K15133 |
| --- | --- | --- | --- |
| General Device Characteristics | Subject Device | Secondary Predicate | Secondary Predicate |
| ILY Photostimulation | | | |
| Trade Name | Ultima System (UL-800-ULTIMA) | Dermalux Flex MD | LightStim for Pain |
| | separate ILY light mode, the ULTIMA UL-800 System is intended to emit energy in the visible red and near-infrared spectrum to provide topical heating for the purpose of elevating tissue temperature, temporarily increasing local blood circulation, and temporarily relaxing muscles. | | |
| Intended Users | Trained Healthcare Professionals | Adult Lay Users | Adult Lay Users |
| Use Environment | Professional Healthcare Facility | Professional and Home Use Settings | Home Use Settings |
| User Interface | The UL-800-ULTIMA Controller device is equipped with 15" multi touch screen and a rotary encoder. When the device is turned on the Graphical User Interface (GUI) appears on the screen. The Controller is designed to control the UL-FACE-LIFT and UL-PAD-IR applicators. Every channel – assigned to separate muscle groups - can be controlled with corresponding buttons on the touchscreen display. The operating interface is used to manage the different programs and settings. | Push button capacitive touch interface. | Push button on/off switch and timer. |
| Prescription | Prescription | Over the Counter | Over the Counter |
| Power Source | External AC/DC Power supply; 24 V DC; 220 W | Battery | Battery |
| Treatment Time | 30 min | Up to 30 min | 5 to 30 min |
| Output Modes | Two EMS, Red Light Stimulation provided independent of each other. | One Multiple Wavelength Photostimulation | One Multiple Wavelength Photostimulation |
| Photostimulation Anatomical Location | Face | Flexible array positioned for face or body treatment; | Belt with 1-4 pods for curved body areas. |
| Treatment Area | 250 cm2 | 792 cm2 | 55 – 220 cm2 |
| Wavelengths (nm) | 660, 730, 940 | Red light: 633nm ±5nm Blue light: 415nm ±5nm NIR light: 830nm ±5nm | 630, 660, 855, 940 |
| Distance from Skin {1} | Min. 20 mm from skin | Not available | Direct contact |
| Avg. Irradiance (W/cm2) {2} | 0.0216 W/cm2 | 0.0055 W/cm2 (415 nm) 0.0115 W/cm2 (633 nm) 0.0055 W/cm2 (830 nm) | 0.060 W/cm2 |
| Radiant Exposure {3} | 33.88 J/cm2 | Red: 20 J/cm2 Blue: 10 J/cm2 NIR: 10 J/cm2 | Calculated upper exposure from public values: 108 J/cm2 at 30 minutes (0.060 W/cm2 x 1,800 s). |
| Max Treatment Duration | Maximum 30 minutes; software timer. | Up to 30 minutes; preset timer/software controls duration. | Recommended 5-30 minutes; automatic shutoff after 30 minutes. |
| Ocular Safety | Mandatory OD ≥ 4 eyewear from 600-1000 nm; clean, completely dry, | Detailed eyewear/preparation values are not stated in the public | Detailed eyewear/preparation values are not stated in the public summary. |
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| Device & Predicate Device(s): | K260945 | K212275 | K15133 |
| --- | --- | --- | --- |
| General Device Characteristics | Subject Device | Secondary Predicate | Secondary Predicate |
| ILY Photostimulation | | | |
| Trade Name | Ultima System (UL-800-ULTIMA) | Dermalux Flex MD | LightStim for Pain |
| | product-free skin; electrodes/cotton removed; stop for excessive heat/discomfort. | summary. | |
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[1] Similar: delivered irradiance is characterized at the subject treatment plane and subject-specific optical, thermal, risk and usability controls address non-contact delivery. Different geometry does not raise a different question of safety or effectiveness.
[2] Same red/NIR scientific technology. LightStim provides exact 660/940 nm overlap; Dermalux supports red/NIR facial delivery; 730 nm lies within the compared red/NIR spectral region and is subject-device characterized.
[3] Similar performance: Subject Device's specified irradiance of 21.6 mW/cm² represents the cumulative output of its three simultaneously operating wavelengths, rather than the output of each wavelength individually. If the three Dermalux wavelengths are likewise operated simultaneously, their reported irradiances provide a cumulative output of approximately 22.5 mW/cm² (11.5 + 5.52 + 5.5 mW/cm²), making the total irradiance of the two devices closely comparable. LightStim, at 60 mW/cm², remains a conservative higher-output predicate comparator. The safety of the Subject Device is independently supported by its own optical and thermal performance testing.
ULTIMA's reported 48 V ceiling is comparable in magnitude to BTL's reported voltage. Its 75 mA system ceiling falls below BTL G1 at 500 Ω but exceeds G2 and G3, so electrode-group matching is essential. ULTIMA's FACEGYM phase is longer and frequency lower. The reported 24 μC system phase charge exceeds every BTL group; the actual facial configuration must be reconciled under Note N1. Lower frequency or average power density alone does not establish equivalence.
The results of the completed evaluations and testing demonstrate that any differences do not raise different questions of safety and effectiveness, and the performance data demonstrate acceptable safety and performance compared to the predicate devices.
## Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The following nonclinical testing was conducted to support the substantial equivalence determination.
The biocompatibility of the subject device is also based on the use of skin-contacting, low biocompatibility risk materials with a long history of safe use in accordance with Attachment G of the FDA/s 2023 Biocompatibility Guidance.
Shelf-life
ASTM F1980-21 - accelerated age testing of the System.
Software Validation, Cybersecurity, Wireless Safety, and Interoperability
• IEC 62304 Software Lifecycle
• Cybersecurity testing
Electrical Safety & Electromagnetic Compatibility Testing
• IEC 60601-1 Electrical Safety
• IEC 60601-1-2 EMC (Immunity & Emissions Testing)
• IEC TS 60601-4-2
• IEC 62471 - Photobiological Classification
• IEC 60601-2-10 - Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
• IEC 60601-2-57- Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use. Note: This is addressed through the optical report's edition-specific applicability/gap assessment; conformity to an out-of-scope edition is not claimed.
Performance Testing (non-clinical benchtop):
• Powered Muscle Stimulator (PMS) characteristics aligned to FDA's PMS Guidance
• Usability Documentation
• Optical Safety and Effectiveness
Conclusion Statement
Therefore, the ULTIMA UL-800 System has the same intended use as the predicate devices. The differences in technological characteristics do not raise new questions of safety and effectiveness, and the performance data demonstrate that the ULTIMA UL-800 System is substantially equivalent to the cleared predicate devices.
