(89 days)
LED red light: The UltraLight" is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs. The UltraLight" is also indicated for use in dermatology for the treatment of superficial, benign vascular, and pigmented lesions.
LED blue light: The UltraLight" is indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
LED green light: The UltraLight "green Light" is indicated for use as a non-invasive dermatological aestheic treatment for the reduction of circumference of hips, waist, and thighs.
The UltraLight LED System is a low level laser system for aesthetic use. The device can emit three different wavelengths (i.e., red light @ 633 nm, blue light @ 415 nm, and green light @ 532 nm) to achieve its intended purpose. All three wavelengths have different indications for use. The device works by illuminating the skin with a single wavelength of red, blue, or green light. The device utilizes a 28.8cm X 38.0 cm irradiation board to deliver light directly to the desired target. The device is activated and controlled through the LCD control panel.
The provided text is a 510(k) Summary for the UltraLight LED System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone clinical study with detailed performance metrics.
Therefore, the following information cannot be fully provided based solely on the given text:
- A detailed table of acceptance criteria and reported device performance for clinical outcomes. The document explicitly states "A human clinical study was not required for this device since the technical specifications of the device are comparable to the technical specifications of the predicates."
- Sample sizes used for a test set (as no clinical test set was required/described).
- Data provenance for a test set.
- Number of experts and their qualifications for establishing ground truth (as no clinical ground truth was established by experts for a test set).
- Adjudication method for a test set.
- Results of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
- Detailed performance metrics for a standalone algorithm, as this is a physical device, not an AI/algorithm-driven one in the context of the typical AI/ML device submission questions. The "Performance Data" section refers to non-clinical testing for safety and technical specifications, not clinical effectiveness.
- The type of ground truth used for performance validation (beyond demonstrating technical equivalence to predicates).
- Sample size for the training set (not applicable as this is not an AI/ML algorithm that requires a training set for clinical performance validation).
- How ground truth for the training set was established (not applicable).
However, I can extract information related to the device and its claimed performance based on its substantial equivalence to predicate devices:
1. A table of Acceptance Criteria and the Reported Device Performance
Since a clinical study was not required for effectiveness, there aren't explicit clinical "acceptance criteria" met by the device itself in this submission in the way you might expect for an AI/ML algorithm. Instead, the device's technical specifications are compared to legally marketed predicate devices to establish substantial equivalence, which is the "acceptance" for market clearance in this context. The "performance" data refers to non-clinical testing ensuring safety and technical adherence.
| Characteristic | Acceptance Criteria (from Predicate Device) | Reported Device Performance (UltraLight LED System) | Indication it addresses |
|---|---|---|---|
| Red Light Mode | |||
| Wavelength | 635 ± 2 nm (Photonica Professional) | 633 nm ± 6 nm | Reduction of hip, waist, and thigh circumference; treatment of superficial, benign vascular, and pigmented lesions. |
| Bandwidth | 10 nm (Photonica Professional) | 10 nm | |
| Output Intensity/Irradiance | 105 mW/cm² (Photonica Professional) | 105 mW/cm² | |
| Recommended Treatment Time | 8 or 20 min (Photonica Professional) | 8 or 20 min | |
| Standard Energy | 126 J/cm² (Photonica Professional) | 126 J/cm² | |
| Blue Light Mode | |||
| Wavelength | 415 ± 5 nm (Omnilux Blue) | 415 nm ± 5 nm | Treatment of moderate inflammatory acne vulgaris. |
| Bandwidth | 22 nm ± 3 nm (Omnilux Blue) | 22 nm | |
| Output Intensity/Irradiance | 33.33 - 47.62 mW/cm² (Omnilux Blue) | 40 mW/cm² | |
| Recommended Treatment Time | 20 min (Omnilux Blue) | 20 min | |
| Max. Energy | 40 J/cm² (Omnilux Blue) | 48 J/cm² | |
| Green Light Mode | |||
| Wavelength | 532 ± 3 nm (Cellulize) | 532 nm ± 3 nm | Reduction of hip, waist, and thigh circumference. |
| Bandwidth | 10 nm (Cellulize) | 10 nm | |
| Output Intensity/Irradiance | 95.14 - 105 mW/cm² (Cellulize) | 95.14 mW/cm² | |
| Recommended Treatment Time | 8 or 20 min (Cellulize) | 8 or 20 min | |
| Max. Energy | 50 J/cm² in 8 min (Cellulize); 126 J/cm² in 20 min (Cellulize) | 45.7 J/cm² in 8 min; 114 J/cm² in 20 min | |
| Safety and EMC | IEC 60601-1 General Requirements for basic safety and essential performance, IEC 60601-1-2 Electromagnetic Compatibility | Tests performed and determined to be compliant. | Device Safety and Electromagnetic Compatibility |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. A human clinical study (test set) was not required or performed for this device to prove clinical effectiveness, as its substantial equivalence was based on technical specifications compared to predicate devices. The "Performance Data" section refers to non-clinical bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. As no clinical test set was required for this submission, no expert ground truth was established for such a set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring adjudication was performed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a physical LED light therapy device, not an AI-based diagnostic or assistive software, so an MRMC study comparing human readers with and without AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an algorithm. Bench performance data was collected to support technical specifications, as stated in the "Performance Data" section, but this is not "standalone algorithm performance."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For clinical effectiveness: No direct clinical ground truth was established for the UltraLight LED System in this submission. The "ground truth" for clearance was the established safety and effectiveness of the predicate devices through their previous clearances. The UltraLight LED System demonstrated substantial equivalence by matching the technical specifications and intended uses of these predicates.
For technical/non-clinical aspects: The ground truth was based on recognized international standards (IEC 60601-1, IEC 60601-1-2) and internal bench testing protocols for physical parameters (wavelength, intensity, etc.).
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML algorithm that utilizes a training set in that context.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
May 24, 2021
Rohrer Aesthetics, LLC Mark Rohrer President 105 Citation Court Birmingham, Alabama 35209
Re: K210535
Trade/Device Name: UltraLight LED System Regulation Number: 21 CFR 878.5400 Regulation Name: Low Level Laser System For Aesthetic Use Regulatory Class: Class II Product Code: OLI Dated: April 29, 2021 Received: May 3, 2021
Dear Mark Rohrer:
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) K210535
Device Name
UltraLight LED System
Indications for Use (Describe)
LED red light: The UltraLight" is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs. The UltraLight" is also indicated for use in dermatology for the treatment of superficial, benign vascular, and pigmented lesions.
LED blue light: The UltraLight" is indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
LED green light: The UltraLight "green Light" is indicated for use as a non-invasive dermatological aestheic treatment for the reduction of circumference of hips, waist, and thighs.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K210535
510(K) Summary
This 510(K) Summary for the UltraLight LED System is prepared in accordance with the requirements of 21 CFR 807.92.
| Applicant: | Rohrer Aesthetics, LLC |
|---|---|
| Address: | Rohrer Aesthetics, LLC105 Citation CourtBirmingham, AL 35209 |
| Contact Person: | Mr. Mark Rohrer |
| Telephone: | 205-356-1172 – phonemrohrer@rohreraesthetics.com |
| Preparation Date: | May 21, 2021 |
| Device Trade Name: | UltraLight LED System |
| Common Name: | Low Level Laser System for Aesthetic Use |
| Regulation Name: | Low Level Laser System for Aesthetic Use |
| Regulation Number: | 21 CFR 878.5400 |
| Product Code: | OLI |
| Predicate Devices: | K180338 (Cellulize), K160880 (Photonica Professional), andK030883 (Omnilux Blue) |
| Regulatory Class: | Class II |
| Device Description: | The UltraLight LED System is a low level laser system foraesthetic use. The device can emit three differentwavelengths (i.e., red light @ 633 nm, blue light @ 415 nm,and green light @ 532 nm) to achieve its intended purpose.All three wavelengths have different indications for use. Thedevice works by illuminating the skin with a singlewavelength of red, blue, or green light. The device utilizes a28.8cm X 38.0 cm irradiation board to deliver light directly tothe desired target. The device is activated and controlledthrough the LCD control panel. |
| Indications for Use: | LED red light: The UltraLight "red light" is indicated for useas a non-invasive dermatological aesthetic treatment for thereduction of circumference of hips, waist, and thighs. TheUltraLight "red light" is also indicated for use in dermatologyfor the treatment of superficial, benign vascular, andpigmented lesions.LED blue light: The UltraLight "blue light" is indicated to treatdermatological conditions and specifically indicated to treat |
moderate inflammatory acne vulgaris.
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LED green light: The UltraLight "green Light" is indicated for
use as a non-invasive dermatological aesthetic treatment for
the reduction of circumference of hips, waist, an
Comparison of Technical Specifications:
| Characteristic - Red Light Mode | UltraLight LED System | Photonica Professional |
|---|---|---|
| (510K Pending) | (K160880) | |
| Wavelength | 633nm±6nm | 635±2nm |
| Bandwidth | 10nm | 10nm |
| Output Intensity/Irradiance | 105mW/cm² | 105mW/cm² |
| Recommended Treatment Time | 8 or 20 min | 8 or 20 min |
| Standard Energy | 126 J/cm² | 126 J/cm² |
| Console Dimension | 35cm×71cm×122cm | 167cm×62cm×61cm |
| Weight | 54kg | 52kg |
| Power Source | 100 - 120vac, 3 amps, 50/60Hz | 110vac, 3 amps, 60Hz |
| Operating Temperature | +5C - +35C | +5C - +35C |
| Cooling Mechanism | Forced Air Ventilation | Forced Air Ventilation |
| Characteristic – Blue Light Mode | UltraLight LED System | Ominlux Blue |
| (510K Pending) | (K030883) | |
| Wavelength | 415nm±5nm | 415±5nm |
| Bandwidth | 22nm | 22nm±3nm |
| Output Intensity/Irradiance | 40mW/cm² | 33.33 - 47.62 mW/cm² |
| Recommended Treatment Time | 20 min | 20 min |
| Max. Energy | 48 J/cm² | 40 J/cm² |
| Console Dimension | 35cm×71cm×122cm | 37cm×18cm×49cm |
| Weight | 54kg | 12kg |
| Power Source | 100 - 120vac, 3 amps, 50/60Hz | 100-120vac, 3 amps, 50/60Hz |
| Operating Temperature | +5C - +35C | +5C - +35C |
| Cooling Mechanism | Forced Air Ventilation | Forced Air Ventilation |
| Characteristic - Green Light | UltraLight LED System | Cellulize |
| Mode | (510K Pending) | (K180338) |
| Wavelength | 532nm±3nm | 532±3nm |
| Bandwidth | 10nm | 10nm |
| Output Intensity/Irradiance | 95.14 mW/cm² | 95.14 - 105 mW/cm² |
| Recommended Treatment Time | 8 or 20 min | 8 or 20 min |
| Max. Energy | 45.7 J/cm² in 8 min | 50 J/cm² in 8 min |
| 114 J/cm²in 20 min | 126 J/cm² in 20 min | |
| Console Dimension | 35cm×71cm×122cm | 183.2cm×62.2cm×61cm |
| Weight | 54kg | 52kg |
| Power Source | 100 - 120vac, 3 amps, 50/60Hz | 100-120vac, 3 amps, 50/60Hz |
| Operating Temperature | +5C - +35C | +5C - +35C |
| Cooling Mechanism | Forced Air Ventilation | Forced Air Ventilation |
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Comparison of Indications for Use:
| UltraLight LED System(510K Pending) | Photonica Professional (K160880) | |
|---|---|---|
| Red Light Mode | For use as a non-invasivedermatological aesthetic treatment forthe reduction of circumference of hips,waist, and thighs. The UltraLight "redlight" is also indicated for use indermatology for the treatment ofsuperficial, benign vascular, andpigmented lesions. | For use as a non-invasivedermatological aesthetic treatment forthe reduction of circumference ofhips, waist, and thighs. PhotonicaProfessional is also indicated for usein dermatology for the treatment ofsuperficial, benign vascular, andpigmented lesions. |
| UltraLight LED System(510K Pending) | Ominlux Blue(K030883) | |
|---|---|---|
| Blue Light Mode | Is indicated to treat dermatologicalconditions and specifically indicatedto treat moderate inflammatory acnevulgaris. | Is indicated to treat dermatologicalconditions and specifically indicated totreat moderate inflammatory acnevulgaris. |
| UltraLight LED System(510K Pending) | Cellulize(K180338) | |
|---|---|---|
| Green LightMode | Is indicated for use as a non-invasivedermatological aesthetic treatment forthe reduction of circumference ofhips, waist, and thighs. | Is indicated for use as a non-invasivedermatological aesthetic treatment forthe reduction of circumference ofhips, waist, and thighs. |
Performance Data: The following performance data were provided in support of (Non-Clinical Testing) the substantial equivalence determination: IEC 60601-1 Test for Medical Electrical equipment was performed for General Requirements for basic safety and essential performance IEC 60601-1-2 Test for Medical Equipment for General Requirements for basic safety and essential performance: electromagnetic compatibility Bench Performance Data to support technical specifications of the device. Results of Clinical Study: A human clinical study was not required for this device since the technical specifications of the device are comparable to the technical specifications of the predicates. Conclusion: The UltraLight LED System is substantially equivalent to the Photonic Professional (K160880), the Omnilux Blue (K030883) and the Cellulize (K180338).
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.