(89 days)
Not Found
No
The device description and performance studies focus on the physical properties of the LED light and its delivery, with no mention of AI or ML for image analysis, diagnosis, or treatment planning. The clinical study was waived based on predicate device comparability, not on performance metrics typically associated with AI/ML algorithms.
Yes
The device is indicated for treating a variety of medical conditions, including superficial, benign vascular, and pigmented lesions, as well as moderate inflammatory acne vulgaris.
No
The device is described as an aesthetic treatment device and is indicated for conditions like circumference reduction, treatment of lesions, and acne vulgaris. It does not perform any diagnostic functions like detection, diagnosis, or monitoring of a disease or condition.
No
The device description explicitly details hardware components such as an irradiation board and an LCD control panel, indicating it is a physical device that emits light, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for various health issues.
- Device Function: The UltraLight LED System is a device that applies light directly to the skin for therapeutic and aesthetic purposes. It does not analyze samples taken from the body.
- Intended Use: The intended uses described (reduction of circumference, treatment of lesions and acne) are all direct treatments applied to the body's surface.
- Device Description: The description details a system that emits light and an irradiation board to deliver it to the skin. There is no mention of sample collection, analysis, or any components typically associated with in vitro testing.
Therefore, the UltraLight LED System falls under the category of a therapeutic or aesthetic medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OLI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hips, waist, thighs, superficial, benign vascular, and pigmented lesions (dermatology), dermatological conditions.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K180338 (Cellulize), K160880 (Photonica Professional), and K030883 (Omnilux Blue)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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)
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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).