← Product Code [GEX](/productcode/GEX) · K210535 # UltraLight LED System (K210535) _Rohrer Aesthetics, LLC · GEX · May 24, 2021 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K210535 ## Device Facts - **Applicant:** Rohrer Aesthetics, LLC - **Product Code:** [GEX](/productcode/GEX.md) - **Decision Date:** May 24, 2021 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Indications for Use 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. ## Device Story UltraLight LED System is a low-level light therapy device for aesthetic dermatology. Device emits three wavelengths: red (633 nm), blue (415 nm), and green (532 nm). System utilizes a 28.8 cm x 38.0 cm irradiation board to deliver light directly to target areas. Operated by clinician via LCD control panel. Red and green light modes target circumference reduction; red light also treats vascular/pigmented lesions; blue light treats moderate inflammatory acne vulgaris. Forced air ventilation provides cooling. Device is intended for professional use in clinical settings. Output is light energy; clinical decision-making relies on provider assessment of patient skin/aesthetic needs. Benefits include non-invasive treatment options for specified dermatological conditions. ## Clinical Evidence No clinical data. Substantial equivalence supported by bench testing and comparison of technical specifications to predicate devices. Bench testing included IEC 60601-1 (general safety/performance) and IEC 60601-1-2 (electromagnetic compatibility). ## Technological Characteristics Low-level LED system; wavelengths: 633nm (red), 415nm (blue), 532nm (green). Irradiation board: 28.8cm x 38.0cm. Power: 100-120VAC, 50/60Hz. Cooling: Forced air ventilation. LCD control panel interface. Class II device. ## Regulatory 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. ## Predicate Devices - Cellulize ([K180338](/device/K180338.md)) - Photonica Professional ([K160880](/device/K160880.md)) - Omnilux Blue ([K030883](/device/K030883.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 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, LLC
105 Citation Court
Birmingham, AL 35209 | | Contact Person: | Mr. Mark Rohrer | | Telephone: | 205-356-1172 – phone
mrohrer@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), and
K030883 (Omnilux Blue) | | Regulatory Class: | Class II | | Device Description: | 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. | | Indications for Use: | LED red light: The UltraLight "red light" is indicated for use
as a non-invasive dermatological aesthetic treatment for the
reduction of circumference of hips, waist, and thighs. The
UltraLight "red light" is also indicated for use in dermatology
for the treatment of superficial, benign vascular, and
pigmented lesions.

LED blue light: The UltraLight "blue light" is indicated to treat
dermatological conditions and specifically indicated to treat | moderate inflammatory acne vulgaris. {4}------------------------------------------------ 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 | {5}------------------------------------------------ #### Comparison of Indications for Use: | | UltraLight LED System
(510K Pending) | Photonica Professional (K160880) | |----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Red Light Mode | For use as a non-invasive
dermatological aesthetic treatment for
the reduction of circumference of hips,
waist, and thighs. The UltraLight "red
light" is also indicated for use in
dermatology for the treatment of
superficial, benign vascular, and
pigmented lesions. | For use as a non-invasive
dermatological aesthetic treatment for
the reduction of circumference of
hips, waist, and thighs. Photonica
Professional is also indicated for use
in dermatology for the treatment of
superficial, benign vascular, and
pigmented lesions. | | | UltraLight LED System
(510K Pending) | Ominlux Blue
(K030883) | |-----------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------| | Blue Light Mode | Is indicated to treat dermatological
conditions and specifically indicated
to treat moderate inflammatory acne
vulgaris. | Is indicated to treat dermatological
conditions and specifically indicated to
treat moderate inflammatory acne
vulgaris. | | | UltraLight LED System
(510K Pending) | Cellulize
(K180338) | |---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------| | Green Light
Mode | Is indicated for use as a non-invasive
dermatological aesthetic treatment for
the reduction of circumference of
hips, waist, and thighs. | Is indicated for use as a non-invasive
dermatological aesthetic treatment for
the reduction of circumference of
hips, 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). --- **Source:** [https://fda.innolitics.com/device/K210535](https://fda.innolitics.com/device/K210535) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com