(466 days)
Not Found
No
The device description and performance studies focus on light therapy and its clinical outcomes, with no mention of AI or ML algorithms for image analysis, treatment planning, or any other function.
Yes
The device is intended to treat specific medical conditions (benign superficial and pigmented lesions) using Red Light (RL) therapy, which aligns with the definition of a therapeutic device.
No
The device is a light-emitting diode therapy system used for treatment, specifically to provide light to the body for the treatment of benign superficial and pigmented lesions. It does not mention any diagnostic capabilities.
No
The device description clearly outlines hardware components including a battery-powered light source (Illuminator), optical fibers, and an optical pad (Light Patch).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Lumina 24 system is a light-emitting diode therapy system that applies light directly to the skin for therapeutic purposes (treating superficial and pigmented lesions). It does not involve the analysis of specimens taken from the body.
- Intended Use: The intended use is for the treatment of skin lesions, not for diagnostic testing of biological samples.
Therefore, the Lumina 24 system falls under the category of a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intended to provide light to the body. Generally indicated to dermatology use for the treatment of benign superficial and pigmented lesions in patients with Fitzpatrick Skin Types II and III excluding vascular lesions such as hemangiomas, telangiectasia, and benign pigmented lesions such as solar lentigo, age spots, or freckles.
Product codes
GEX
Device Description
The Rogers Sciences Inc.'s Lumina 24 is a light-emitting diode therapy system used to treat superficial and pigmented skin lesions. It consists of a battery-powered light source (Illuminator), optical fibers, and an optical pad (Light Patch). The Light Patch and its adhesive are made from hypoallergenic materials designed to be safe for Fitzpatrick Skin Types II and III.
The Lumina 24 system applies Red Light (RL) therapy directly to the treatment area of the skin. To begin treatment, the patient applies the Light Patch to the treatment area and turns on the Illuminator. Light travels from the Illuminator through the optical connector to the Light Patch and to the skin. The Illuminator turns off automatically after 1 hour but treatment may be stopped at any time by turning it off manually. Because Lumina 24 is portable and battery-powered, treatment can take place while the patient is doing other activities.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Torso below neck, legs, arms/biceps
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: Prospective, randomized, controlled, masked study.
Sample Size: 17 subjects completed the study. Of the 17 subjects, four (4) had lesions on both sides of their legs. Two (2) of these subjects had lesions on the lower leg, and the other two (2) subjects had lesions on the upper leg. Five (5) subjects had lesions on both sides of their upper chest. The remaining eight (8) subjects had lesions on both sides of their arms/biceps.
AUC: Not Found
MRMC: Not Found
Standalone Performance:
The Lumina 24 Illumination Device had mW/cm2 measurements ranging from 1.14 to 1.23 before the study and 1.12 to 1.23 after the study.
The Lumina 24 Light Patch had mW/cm2 measurements ranging from 0.5281 to 0.6119 before the study and 0.5263 to 0.6087 after the study.
The average uniformity of the Lumina 24 Light Patch before the study ranged from -2.51% to 8.95%, and after the study ranged from -4.94% to 9.25%.
The repeatability difference for the Lumina 24 Illumination Device ranged from -1.79% to 1.71%.
The repeatability difference for the Lumina 24 Light Patch ranged from -1.99% to 2.64%.
Key Results:
The study compared the Lumina 24 system and the EVIS MD Platinum system for the treatment of superficial and pigmented lesions in patients with Fitzpatrick Skin Types II and III.
Primary Endpoint: Evaluated % clearance of lesions based on a quartile scale (ex. Q1: >75%). Clearance was determined by the exact number of lesions counted at an anatomical site before (pre) or after (post) treatment. Post-treatment evaluation occurred one-month after completing treatment. Evaluation was performed by a panel of four independent dermatology providers who were blinded as to treatment used and whether the site was pre or post-intervention. The evaluators based the lesion counts on high-resolution digital images taken by the Principal Investigator. The percent clearance was calculated by the formula: ((BT - PT) / BT) x 100.
Secondary Endpoints: Mean score on subject satisfaction with skin appearance scale at 1 week, 2 weeks, 3 weeks and at 1 month follow-up visit using the 100mm Visual-Analog-Scale (VAS). Self-reported adverse events. Evaluate safety of the Lumina 24 Light Patch (LP) by measuring pre- and post- uniformity and repeatability (Uniform: irradiance at each measurement point within +/-20% of the mean irradiance value; Repeatable: irradiance at each measurement point within +/-20% of the median over 3 distinct measurements).
Patient Response: The week to week response variation per subject was not significant for both devices. The variation in satisfaction across all subjects for all weeks was not significant. The variation in satisfaction between devices for all weeks and all subjects was not significant. No Adverse Events were reported by any subjects.
Device Testing: Little change in irradiance output across the devices from before and after the study. Repeatability shows less than 3% difference in light output. Uniformity on a given LP and across all LPs was less than 10%. Uniformity between devices before and after study was less than +/-20%.
Percent Clearance: A panel of 4 experts, blinded, reviewed 1-month visit photos and evaluated lesion counts.
Q1 (76-100% clearance): Lumina24: 1, EVIS: 1
Q2 (51-75% clearance): Lumina24: 0, EVIS: 1
Q3 (26-50% clearance): Lumina24: 6, EVIS: 5
Q4 (0-25% clearance): Lumina24: 10, EVIS: 10
Statistical Significance: Chi Square analysis of the Quartile results yielded p=0.78. Study has >80% probability detecting a 15% or greater difference in lesion clearance between Lumina and Evis at p=0.05.
Conclusion: Devices are substantially equivalent in clearance of lesions related to photo aging. There was no statistically significant difference between the two devices (significant difference defined as an 80% confidence that there is less than 20% difference). No adverse events were reported for either device.
Key Metrics
Mean VAS (10 pt Scale) for All Subjects
Lumina24: Week 1: 3.9000, Week 2: 4.6857, Week 3: 5.2500, Week 4: 5.7429, Weekly Avg.: 4.8946
EVIS: Week 1: 4.2964, Week 2: 4.7250, Week 3: 5.4214, Week 4: 5.9214, Weekly Avg.: 5.0911
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines suggesting movement or connection. The profiles are rendered in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 26, 2015
Rogers Sciences Incorporated % Mr. Raymond Kelly Licensale Incorporated 1801 Wedemeyer Street San Francisco, California 94129
Re: K140386 Trade Name: Lumina 24 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology. Regulatory Class: Class II Product Code: GEX Dated: May 14, 2015 Received: May 18, 2015
Dear Mr. Kelly:
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. 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.
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
1
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K140386
Device Name Rogers Sciences Inc (RSI) Lumina 24
Indications for Use (Describe)
Intended to provide light to the body. Generally indicated to dermatology use for the treatment of benign superficial and pigmented lesions in patients with Fitzpatrick Skin Types II and III excluding vascular lesions such as hemangiomas, telangiectasia, and benign pigmented lesions such as solar lentigo, age spots, or freckles.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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ROGERS SCIENCES, INC.
Address: 79 Golf Street, Southbridge, MA 01550 USA Phone: 888-691-2321 Web: www.rogerssciencesinc.com
510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.(c)
Date Prepared: May 26, 2015
Applicant Rogers Science Inc. 79 Golf Street, Southbridge, MA 01550 USA Phone: 617-435-5152 Web: www.rogerssciencesinc.com
Contact Person Raymond Kelly Licensale Inc. 57 Lazy Brook Rd Monroe, CT 06468 USA Phone: (203) 880-4091
| Device Information | |
|---|---|
| Trade/Proprietary Name: | Lumina 24 |
| Common Name: | Powered Laser Surgical Instrument |
| Classification Name: | Laser Surgical Instrument |
| Regulation Medical Specialty: | General & Plastic Surgery |
| Review Panel: | General & Plastic Surgery |
| Product Code: | GEX |
| Device Class: | 2 |
| Regulation Number: | 878.4810 |
Predicate Device Information K082247 "Evis MD Platinum Red Light Therapy" cleared by FDA on October 10, 2008
Indications for Use
Intended to provide light to the body. Generally indicated to dermatology use for the treatment of benign superficial and pigmented lesions in patients with Fitzpatrick Skin Types II and III excluding vascular lesions such as hemangiomas, telangiectasia, and benign pigmented lesions such as solar lentigo, age spots, or freckles.
4
Device Description
The Rogers Sciences Inc.'s Lumina 24 is a light-emitting diode therapy system used to treat superficial and pigmented skin lesions. It consists of a battery-powered light source (Illuminator), optical fibers, and an optical pad (Light Patch). The Light Patch and its adhesive are made from hypoallergenic materials designed to be safe for Fitzpatrick Skin Types II and III.
The Lumina 24 system applies Red Light (RL) therapy directly to the treatment area of the skin. To begin treatment, the patient applies the Light Patch to the treatment area and turns on the Illuminator. Light travels from the Illuminator through the optical connector to the Light Patch and to the skin. The Illuminator turns off automatically after 1 hour but treatment may be stopped at any time by turning it off manually. Because Lumina 24 is portable and batterypowered, treatment can take place while the patient is doing other activities.
Substantial Equivalence
Equivalence was determined using a side by side tabular comparison between the predicate and proposed devices which included: Features, Intended Use, Labeling, Materials, Specifications, Performance Data, and Technological Aspects.
| Basic Unit
Characteristics | Lumina 24 | K082247
EVIS MD Platinum Red Light
Therapy |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | Intended to provide light to the body.
Generally indicated to dermatology use
for the treatment of superficial and
pigmented lesions in patients with
Fitzpatrick Skin Types II and III
excluding vascular lesions such as
hemangiomas, telangiectasia, or other
benign pigmented lesions such as solar
lentigo, age spots, or freckles. | Intended to provide light to the body.
Generally indicated to dermatology
use for the treatment of superficial,
benign vascular and pigmented
lesions "such as but not limited to
solar lentigines, sun spots, liver spots
and age spots. |
| Power (mW) | $0.417 \pm 20%$ | 80.00 |
| Increments of Power
Available (mW) | $0.417 \pm 20%$
$0.834 \pm 20%$ | 80.00 |
| Irradiance (mW/cm²) | $0.580 \pm 20%$ | 80.00 |
| Fluence (J/cm²) | 2.088 | 192.00 |
| Duration (min) | 60 | 20 |
| Beam Diameter (mm) | 7.5 | 7.5 |
| Pulse Rate (Hz) | Continuous | Continuous |
| Pulse Duration (ms) | 0 | 0 |
| Spot Size at Target (cm²) | 79 | 79 |
| Wavelength (nm) | $630 \pm 5$ | $630 \pm 5$ |
| Beam Mode | LED, 42 mil square | LED, 42 mil square |
| Beam Divergence Angle
(Deg.) | 0.5" aperature (Theta = 30) | 0.5" aperature (Theta = 30) |
| Aiming Beam Type
(Wavelength) | $630 \pm 5$ | $630 \pm 5$ |
| Controls
(Power, Readouts) | Display, control buttons | Display, control buttons |
| Laser Medium | Light Emitting Diode | Light Emitting Diode |
| Basic Unit
Characteristics | Lumina 24 | K082247
EVIS MD Platinum Red Light
Therapy |
| Energy Source | Red Light | Red Light |
| Cooling Method | Air | Air |
| Display (Control Panel,
Printouts) | display; control buttons | display; control buttons |
| Power Calibration | NA | NA |
| Clean/Disinfect | Wipe with alcohol between use | Wipe with alcohol between use |
| Software | None | None |
| Timer | Begins counting at the time the Power
Switch is tuned On and the Light Patch
establishes contact with the
Illumination Device. After 1-hour the
power is turned off | Begins counting at the time tuned on;
20 Minutes per target area, 2
treatments per week. Audible beep
every 3 minutes for 20 minutes,
Timer to turn off the power after 1-
hour |
| Treatment Length | 4 weeks first phase, maintenance long
term | 4-8 weeks first phase, maintenance
long term |
| Treatment Area | Torso below neck | Torso below neck |
| Handpiece Shape | Rectangular shaped | Rectangular shaped |
| Handpiece Material | Biocompatible polymer with adhesive
strip | Biocompatible polymer with
adhesive strip |
| Handpiece Thickness | ≤ 8 mm | ≤ 8 mm |
| Handpiece Weight | ≤ 50 grams | ≤ 50 grams |
| Voltage Current | Set by potentiometer | Set by potentiometer |
| On-Off Button | External On/Off push-button | External On/Off push-button |
| Power Safeguard | If current from the battery increases
beyond a threshold, the Power
Safeguard shuts off power | If current from the battery increases
beyond a threshold, the Power
Safeguard shuts off power |
| Status Indicator
Conditions | On-Off status, self-test, failures,
disconnect during treatment, fault
condition, therapy completion | On-Off status, self-test, failures,
disconnect during treatment, fault
condition, therapy completion |
| Therapy Thermal cut-out | When the LED approaches 50°C
junction temperature, the internal
thermistor allows system to shut off | When the LED approaches 50°C
junction temperature, the internal
thermistor allows system to shut off |
| Surface Temperature | Surface temperature
≤ 43°C and meets IEC 60601-1 | Surface temperature
≤ 43°C and meets IEC 60601-1 |
| Surface Temperature
Dissipation | Temperature does not exceed 43°C | Temperature does not exceed 43°C |
| Positioning On Subject | Able to be placed on the target location
by the user | Able to be placed on the target
location by the user |
| Storage conditions | 10-27°C and 40-60%RH | 10-27°C and 40-60%RH |
| Electrical Safety | Compliant to safety requirements for
electrical equipment IEC60601-1 | Compliant to safety requirements for
electrical equipment IEC60601-1 |
| Cabling/Coupling
Electrical Safety | Compliant to requirements for patient-
applied parts with a Type BF rating.
This is the requirement for electrical
isolation in terms of high-potential
dielectric withstand and current
leakage | Compliant to requirements for
patient-applied parts with a Type BF
rating. This is the requirement for
electrical isolation in terms of high-
potential dielectric withstand and
current leakage |
| Shelf Life | 12 months shelf and 12 months Useful
Life | 12 months shelf and 12 months
Useful Life |
5
6
Clinical Summary:
Study Objective
This study compared the Light Emitting Diode therapy of the Lumina 24™ system and the EVIS MD Platinum system. Both of these systems use Red Light (630mm) technology. Both of these systems were compared for the treatment of superficial and pigmented lessions in patients with Fitzpatrick Skin Types II and III excluding vascular lesions such as hemangiomas, telangiectasia, or other benign pigmented lesions such as solar lentigo, age spots, or feckles.
Primary Endpoint
- Evaluated % clearance of lesions based on a quartile scale (ex. 01: >75%). Clearance . was determined by the exact number of lesions counted at an anatomical site before (pre) or after (post) treatment with one of the study devices (Lumina24 or EVIS MD). Posttreatment evaluation occurred one-month after completing treatment. Evaluation was performed by a panel of four independent dermatology providers who were blinded as to treatment used and whether the site was pre or post-intervention. The evaluators based the lesion counts on high-resolution digital images taken by the Principal Investigator.
The percent clearance was calculated by the following formula:
((BT - PT) / BT) x 100 = percent reduction in lesions, where
BT = before treatment lesion number in the anatomic area treated PT = post treatment lesion number in the anatomic area treated
The subjects were then grouped into four Quartiles, where:
- Q1 = greater than 75% clearance of lesions
- Q2 = 50% 75% clearance of lesions
- O3 = 25% -50% clearance of lesions
- Q4 = less than 25% clearance of lesions
Secondary Endpoints
- Mean score on subject satisfaction with skin appearance scale at 1 week, 2 weeks, 3 . weeks and at 1 month follow-up visit using the 100mm Visual-Analog-Scale (VAS), with 0 being very dissatisfied and 10 being very satisfied.
- Self-reported adverse events as documented on subject log ●
- Evaluate safety of the Lumina 24™ Light Patch (LP). Rogers Sciences (manufacturer of ● the Lumina 24™ system) measured pre- and post- uniformity and repeatability of each LP used in the study. 'Uniform' is specified as irradiance at each measurement point within +/-20% of the mean irradiance value. 'Repeatable' is specified as irradiance at each measurement point within +/-20% of the median over 3 distinct measurements. Measurements to be taken with a calibrated photometer.
7
Study Methodology
This was a prospective, randomized, controlled, masked study. Subjects meeting all inclusion/exclusion criteria and consenting to participation were enrolled and given both the Lumina 24™ system and the EVIS MD Platinum for use at home to be applied to designated treatment areas chosen by the study clinician. The clinician picked a treatment location on the arms, legs, back, chest, and/or torso. The clinician selected a part of the body which had damaged skin on an area that is equal on both sides (symmetrical) of the body. Only one treatment area. for each side of the body was identified by the clinician for treatment. Randomization using standard randomization number table determined which device was used on the right and left side of the body. The treatment locations and how to apply a device to a given location were described and shown by the Principal Investigator to the subject. The subject used each device twice a week; both devices were applied on a Monday and Wednesday. Each device was applied on the same day but at separate times (the devices were not be applied and used simultaneously on a given treatment day). The Lumina 24™ system was applied for a 1-hr time period and the EVIS MD Platinum was applied for 18 minutes. Self-assessments were documented weekly (weeks 1, 2. and 3) and at 1 month (30 days +/- 7 days) for satisfaction with skin appearance. Adverse events were self-assessed as applicable. Photographs of each treatment site for each device were taken pre- and post- treatment.
STUDY RESULTS
A total of 17 subjects completed the study. Of the 17 subjects, four (4) had lesions on both sides of their legs. Two (2) of these subjects had lesions on the lower leg, and the other two (2) subjects had lesions on the upper leg. Five (5) subjects had lesions on both sides of their upper chest. The remaining eight (8) subjects had lesions on both sides of their arms/biceps.
| Eight (8) subjects had a Fitzpatrick Skin Type of 2 and the remaining nine (9) subjects had a | |
|---|---|
| Fitzpatrick Skin Type of 3. |
| Patient | Anatomical | Fitzpatrick | Side of Body | Side of Body |
|---|---|---|---|---|
| Number | Location | Skin Type | EVIS Applied | Lumina24 Applied |
| 1 | Upper Leg | 2 | Left | Right |
| 2 | Chest | 3 | Right | Left |
| 3 | Chest | 3 | Right | Left |
| 4 | Upper Leg | 3 | Right | Left |
| 5 | Lower Leg | 2 | Left | Right |
| 6 | Lower Leg | 3 | Left | Right |
| 7 | Chest | 2 | Left | Right |
| 8 | Chest | 2 | Left | Right |
| 9 | Arm | 2 | Left | Right |
| 10 | Chest | 3 | Right | Left |
| 11 | Arm | 2 | Left | Right |
| 12 | Arm | 2 | Left | Right |
| 13 | Arm | 3 | Left | Right |
| 14 | Arm | 3 | Right | Left |
| 16 | Arm | 3 | Left | Right |
| 17 | Arm | 2 | Left | Right |
| 19 | Arm | 3 | Right | Left |
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Patient Response
On a weekly basis subjects filled out a study log for both the Lumina24 and EVIS MD Platinum system. As part of the log, each subject marked their satisfaction with their skin appearance after treatment at 1 week, 2 weeks, 3 weeks, and at 1-month follow up visit using the 100mm VAS. The week to week response variation per subject was not significant for both the Lumina24 and EVIS MD Platinum systems. The variation in satisfaction across all subjects for all weeks was not significant. The variation in satisfaction between devices for all weeks and all subjects was not significant.
No Adverse Events were reported by any subjects during their treatments with either the Lumina24 or EVIS MD Platinum system devices.
| Mean VAS (10 pt Scale) for All Subjects (Based on Device) | |||||
|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 3 | Week 4 | Weekly Avg. | |
| Lumina24 | 3.9000 | 4.6857 | 5.2500 | 5.7429 | 4.8946 |
| EVIS | 4.2964 | 4.7250 | 5.4214 | 5.9214 | 5.0911 |
| BEFORE | AFTER | ||||||
|---|---|---|---|---|---|---|---|
| Lumina24 | |||||||
| Illumination | |||||||
| Device | Light Patch | EVIS | |||||
| Device | Lumina24 | ||||||
| Illumination | |||||||
| Device | Light Patch | EVIS | |||||
| Device | |||||||
| Subject | mW/cm2 | mW/cm2 | mW/cm2 | Subject | mW/cm2 | mW/cm2 | mW/cm2 |
| 1 | 1.15 | 0.5946 | 12.15 | 1 | 1.16 | 0.5947 | 12.22 |
| 2 | 1.19 | 0.5524 | 10.85 | 2 | 1.19 | 0.5434 | 10.82 |
| 3 | 1.22 | 0.5532 | 11.02 | 3 | 1.22 | 0.5424 | 11.00 |
| 4 | 1.14 | 0.5501 | 10.99 | 4 | 1.12 | 0.5650 | 10.94 |
| 5 | 1.16 | 0.5843 | 11.03 | 5 | 1.15 | 0.5796 | 11.01 |
| 6 | 1.15 | 0.5409 | 12.09 | 6 | 1.15 | 0.5374 | 12.11 |
| 7 | 1.15 | 0.6119 | 12.08 | 7 | 1.16 | 0.6087 | 12.10 |
| 8 | 1.18 | 0.5459 | 10.87 | 8 | 1.18 | 0.5452 | 10.88 |
| 9 | 1.19 | 0.5932 | 12.14 | 9 | 1.20 | 0.5914 | 12.13 |
| 10 | 1.19 | 0.5281 | 10.85 | 10 | 1.18 | 0.5263 | 10.85 |
| 11 | 1.23 | 0.5329 | 11.00 | 11 | 1.23 | 0.5333 | 11.01 |
| 12 | 1.21 | 0.6020 | 11.01 | 12 | 1.20 | 0.6018 | 11.00 |
| 13 | 1.15 | 0.5949 | 10.85 | 13 | 1.17 | 0.5902 | 10.84 |
| 14 | 1.16 | 0.5688 | 12.07 | 14 | 1.17 | 0.5671 | 12.07 |
| 16 | 1.16 | 0.5737 | 12.05 | 16 | 1.17 | 0.5741 | 12.06 |
| 17 | 1.14 | 0.5767 | 11.07 | 17 | 1.15 | 0.5707 | 11.08 |
| 19 | 1.18 | 0.5683 | 10.85 | 19 | 1.17 | 0.5677 | 10.89 |
Before and after test measurements of the Study Devices. Measurements are of irradiance (mW/cm²).
9
Lumina24 Device Testing
Device testing on the light output of the Lumina24 Illumination Device and Light Patches (LP) as well as on the EVIS MD Platinum System were undertaken before and after subjects used the devices during their study treatment. For the LPs, each one was measured before and after treatment for uniformity and repeatability.
There was little change in irradiance output across the devices from before and after the study took place for a given subject. The repeatability of these devices shows that there was less than a 3% difference in light output before and after the study for each subject.
The uniformity on a given LP and across all the LPs given to subject was less than 10% before and after the study. The uniformity between the devices before and after the study for each subject was less than +/-20%.
The Lumina24 system for each subject held up to the specifications of uniformity and repeatability outlined as secondary endpoints of the clinical study.
| AVERAGE UNIFORMITY | |||
|---|---|---|---|
| Lumina24 | |||
| Light Patch | |||
| Before | Light Patch | ||
| After | Difference | ||
| Before and | |||
| After | |||
| Subject | mW/cm2 | mW/cm2 | mW/cm2 |
| 1 | -2.51% | -2.53% | -0.23% |
| 2 | 4.75% | 6.30% | -1.83% |
| 3 | 4.62% | 6.48% | -1.78% |
| 4 | 5.15% | 2.59% | 2.40% |
| 5 | -0.75% | 0.08% | -0.92% |
| 6 | 6.74% | 7.34% | -0.68% |
| 7 | -5.50% | -4.94% | -0.45% |
| 8 | 5.88% | 6.00% | -0.08% |
| 9 | -2.28% | -1.97% | -0.26% |
| 10 | 8.95% | 9.25% | -0.32% |
| 11 | 8.12% | 8.05% | 0.10% |
| 12 | -3.79% | -3.75% | -0.02% |
| 13 | -2.57% | -1.76% | -0.79% |
| 14 | 1.93% | 2.22% | -0.29% |
| 16 | 1.09% | 1.02% | 0.09% |
| 17 | 0.57% | 1.61% | -1.00% |
| 19 | 2.01% | 2.13% | -0.12% |
Uniformity test measurements of the Study Devices. Measurements are of irradiance (mW/cm2) difference from before and after the study on a given device used by a subject.
| REPEATABILITY DIFFERENCE | |||
|---|---|---|---|
| Lumina24 | EVIS | ||
| Illumination | |||
| Device | Light Patch | Device | |
| Subject | mW/cm2 | mW/cm2 | mW/cm2 |
| 1 | 0.86% | 0.02% | 0.57% |
| 2 | 0.00% | -1.66% | -0.28% |
| 3 | 0.00% | -1.99% | -0.18% |
| 4 | -1.79% | 2.64% | -0.46% |
| 5 | -0.87% | -0.82% | -0.18% |
| 6 | 0.00% | -0.64% | 0.17% |
| 7 | 0.86% | -0.53% | 0.17% |
| 8 | 0.00% | -0.12% | 0.09% |
| 9 | 0.83% | -0.30% | -0.08% |
| 10 | -0.85% | -0.34% | 0.00% |
| 11 | 0.00% | 0.08% | 0.09% |
| 12 | -0.83% | -0.04% | -0.09% |
| 13 | 1.71% | -0.79% | -0.09% |
| 14 | 0.85% | -0.29% | 0.00% |
| 16 | 0.85% | 0.08% | 0.08% |
| 17 | 0.87% | -1.05% | 0.09% |
| 19 | -0.85% | -0.12% | 0.37% |
Repeatability test measurements of the Study Devices. Measurements are of irradiance (mW/cm2) difference from before and after the study on a given device used by a subject.
10
Percent Clearance
Within 30 days of last subject completing 1 month visit, a panel of 4 experts, in a blinded manner, reviewed the 1 month visit photos of the treated sites from all enrolled subjects and evaluated the number of lesions for a given anatomical site before (pre) or after (post) treatment using one of the treatment devices. The following are the quartile scale of percent lesions clearance before and after treatment with the Lumina24 and EVIS MD Platinum systems.
| ALL PATIENTS | N=17 | |
|---|---|---|
| Quartile | ||
| Clearance | ||
| Lumina24 | Quartile | |
| Clearance | ||
| EVIS | ||
| Q1: 76-100% | 1 | 1 |
| Q2: 51-75% | 0 | 1 |
| Q3: 26-50% | 6 | 5 |
| Q4: 0-25% | 10 | 10 |
Percent lesions clearance based on quartile scale for each device across all patients (N=17).
The 2 x 4 matrix was evaluated for statistical significance by a Chi Square analysis of the Quartile results with the following outcome:
- . Chi Square of the Quartile analysis: p=0.78
- . Study has >80% probability detecting a 15% or greater difference in lesion clearance between Lumina and Evis at p=0.05
- . Conclusion: Devices are substantially equivalent in clearance of lesions related to photo aging.
Conclusion
Based on the results of the 4-member review panel of the pre- and post- images of the 17 subjects who were treated with the Lumina24 system and the EVIS Platinum MD system, there was no statistically significant difference between the two devices. Significant difference being defined as an 80% confidence that there is less than 20% difference between the Lumina24 system and the EVIS Platinum MD system. Furthermore none of the 17 subjects enrolled had an AE (Evis AE =0, Lumina24=0).
Due to the lack of difference in clinical response to the two devices as determined by an independent and qualified review panel. RSI has determined and demonstrated that the Lumina24 system and the EVIS MD Platinum system are clinically Substantially Equivalent (SE).