(125 days)
No
The description of the device's functionality, particularly the skin tone sensor and intensity levels, relies on pre-programmed logic and sensors, not adaptive learning or complex pattern recognition characteristic of AI/ML. There is no mention of AI, ML, or related terms in the summary.
No.
The "Intended Use" explicitly states that the device is "intended for the removal of unwanted hair," which is a cosmetic purpose, not a therapeutic one. Additionally, the device is marketed as an "over-the-counter" hair remover for home use.
No
The device is intended for the removal of unwanted hair, which is a treatment or cosmetic purpose, not for diagnosing a condition.
No
The device description explicitly details hardware components such as a handset, external power supply, quartz light tube, cooling system, and sensors, indicating it is a physical device, not software-only.
Based on the provided information, the Lumilisse IPL Hair Remover is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "removal of unwanted hair." This is a cosmetic or aesthetic purpose, not a diagnostic one.
- Device Description: The device uses Intense Pulsed Light (IPL) to target hair follicles. This is a physical process applied to the body, not a test performed on a sample taken from the body.
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The Lumilisse IPL Hair Remover does not perform any such tests on specimens.
Therefore, the Lumilisse IPL Hair Remover is a medical device, but it falls under a different classification than IVD devices.
N/A
Intended Use / Indications for Use
The Lumilisse IPL (Intense Pulsed Light) Hair Remover is an over-the-counter device intended for the removal of unwanted hair.
Product codes (comma separated list FDA assigned to the subject device)
OHT
Device Description
The Lumilisse IPL Hair Remover (Figure 11.1) is a hair-removal device that eliminates unwanted hair from the body (legs and arms), and from more sensitive areas (underarms, bikini line, lower half of the face - below the cheekbones) using intense pulse light technology.
The Lumilisse IPL Hair Remover is an Intense Pulsed Light (IPL) system consisting of:
- Handset - contained within the handset is the High Voltage Capacitor, Capacitor Charger, Control Electronics and Firmware, Quartz Light Tube, Cooling System, Skin Tone and Skin Contact Sensors and the firmware for operation and safety.
- External Power Supply – used to convert the electricity from the mains supply (either 110V or 230V, 50/60Hz) to a much lower DC value. This power supply unit is an "off-theshelf" component which meets all the relevant electrical safety standards.
- Skin Color Sensor System - For effective and safe treatment, the Lumilisse IPL Hair Remover is equipped with the Skin Sensor System, a skin color detection system that automatically regulates the light intensity applied to the skin.
- Levels of Intensity - The Lumilisse IPL Hair Remover features 5 levels of intensity, running from the lowest (level 1) to the highest (level of intensity indicates the intensity of the pulsed light applied to the skin when using the Lumilisse Hair Remover.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Intense Pulsed Light (IPL)
Anatomical Site
Body (legs and arms), underarms, bikini line, lower half of the face (below the cheekbones).
Indicated Patient Age Range
21 and older
Intended User / Care Setting
Home Use
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)
Usability Study: A Human Factors Usability study was conducted using 20 participants to demonstrate the participants were capable of reading the instruction manual and were then able to use the Lumilisse IPL Hair Remover correctly. The Conair Lumilisse IPL Hair Remover was found to be safe and effective for the intended users, uses and use environments based on the results of our simulated use study, biocompatibility testing.
Clinical Study: A clinical study was conducted comparing the G920 and G930 IPL Hair Remover (European pre-cursor to the IPL960F Lumilisse Hair Remover) hand-held systems to evaluate the in-vivo efficacy and cutaneous acceptability on the legs and cutaneous acceptability for the underarms and half-upper lips.
Each of the two units had a significant effect in lowering the amount and density of hairs in regions tested. The only safety events appear to be unrelated to the units, themselves. The dermatological evaluation was positive for safety, and the final study results, for the large majority of the test Subjects, was that the units had the desired effects.
The comparative study concluded the Lumilisse Hair Remover reduction results last for 6 months with over 75% less hair on legs and concluded cutaneous acceptability for legs, underarms and half-upper lip.
The study concluded Lumilisse Hair Removal Systems as safe and effective when used according to instructions.
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.
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.
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 18, 2018
Conair Corporation % Mr. E.J. Smith Smith Associates 1468 Harwell Avenue Crofton, Maryland 21114
Re: K172791
Trade/Device Name: Lumilisse IPL Hair Remover 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: OHT Dated: October 20, 2017 Received: October 20, 2017
Dear Mr. Smith:
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 of medical device-related adverse events) (21 CFR 803); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Jennifer R. Stevenson -ડર્ 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) K172791
Device Name Lumilisse Hair Removal System
Indications for Use (Describe)
The Lumilisse IPL (Intense Pulsed Light) Hair Remover is an over-the-counter device intended for the removal of unwanted hair.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
| Sponsor: | Conair Corporation |
|---|---|
| Address: | One Cummings Point Road |
| Stamford, CT 06902 | |
| Telephone Number: | 203-975-4617 |
| Contact Person: | Mike Cantrell |
| Regulatory Compliance | |
| Email: | mike_cantrell@conair.com |
| Summary Preparation Date: | January 18, 2018 |
| Device Name: | |
| Classification Name: | Light based OTC Hair Remover |
| Common/Usual Name: | Light based OTC Hair Remover |
| Proprietary Name: | Lumilisse IPL Hair Remover |
| Establishment Registration: | 1222304 |
| Classification: | Class II |
| Product Code: | OHT |
| Code of Federal regulation: | 21 CFR 878.4810 |
| Review Panel: | General Surgery Devices Branch One - Light Based/Laser |
Predicate Device:
| Predicate | Manufacturer | Brand Name | 510(k) Number |
|---|---|---|---|
| Primary | Home Skinovations Ltd. | Silk'n Flash N Go | K103184 |
| Reference | Syneron Beauty Ltd. | mē | K131649 |
| Reference | CyDen Ltd. | iPulse Smoothskin | |
| Gold | K160968 |
Device Description:
The Lumilisse IPL Hair Remover (Figure 11.1) is a hair-removal device that eliminates unwanted hair from the body (legs and arms), and from more sensitive areas (underarms, bikini line, lower half of the face - below the cheekbones) using intense pulse light technology.
4
The Lumilisse IPL Hair Remover is an Intense Pulsed Light (IPL) system consisting of:
- . Handset - contained within the handset is the High Voltage Capacitor, Capacitor Charger, Control Electronics and Firmware, Quartz Light Tube, Cooling System, Skin Tone and Skin Contact Sensors and the firmware for operation and safety.
- External Power Supply – used to convert the electricity from the mains supply (either 110V or 230V, 50/60Hz) to a much lower DC value. This power supply unit is an "off-theshelf" component which meets all the relevant electrical safety standards.
- Skin Color Sensor System - For effective and safe treatment, the Lumilisse IPL Hair Remover is equipped with the Skin Sensor System, a skin color detection system that automatically regulates the light intensity applied to the skin.
- . Levels of Intensity - The Lumilisse IPL Hair Remover features 5 levels of intensity, running from the lowest (level 1) to the highest (level of intensity indicates the intensity of the pulsed light applied to the skin when using the Lumilisse Hair Remover.
The Lumilisse Hair Remover can be used by men and women aged 21 and older.
Device Indications for Use:
The Lumilisse IPL (Intense Pulsed Light) Hair Remover is an over-the-counter device intended for the removal of unwanted hair.
Discussion of Technological Characteristics:
Discussion of Similarities
The Lumilisse IPL Hair Remover and the predicate devices have IPL technology, capacitancebased skin contact sensor such that if the flash port is not in direct contact with the skin (covering the entire port) the unit will not flash, skin tone sensors, pulse durations for use, use environment, user group, power source, operating/storage temperature and relative humidity conditions. The Lumilisse IPL Hair Remover has the identical wavelengths as the mē.
Discussion of Differences K103184:
The Lumilisse IPL Hair Remover lowest light intensity reading is 2.0 J/cm² versus predicate's lowest light intensity of 3.0 - 5.0 J/cm² and the Lumilisse IPL Hair Remover wavelength range is 550 nm - 1200 nm versus the predicate device wavelength range of 475 nm - 1200 nm. The differences in light intensity and wavelength raise no new issues of safety and effectiveness.
Discussion of Differences K131649:
The Lumilisse IPL Hair Remover maximum light intensity is 4.5 J/cm² versus the predicate's maximum light intensity of 4 J/cm² and the difference raises no new issues of safety and effectiveness.
5
Discussion K160968:
The Lumilisse IPL Hair Remover has a wavelength of 550-1200m and the predicate has a wavelength of 510-1100nm. The Lumilisse IPL Hair Remover has a light intensity of 2.0 J/cm² and the predicate has a maximum optical of 3-6 J/cm². The Lumilisse IPL Hair Remover automatically controls the repetition rate for Level 1.6 seconds and Level 5, 1 pulse every 3.5 seconds, whereas, the predicate states their repetition rate as manually, 1 pulse every 1-2 seconds. The differences in wavelength, light intensive no new issues of safety and effectiveness.
| Parameters | Conair
Lumilisse IPL Hair
Remover | Home Skinovations
Ltd
Silk'n Flash N Go | Syneron Beauty Ltd.
mē | CyDen Ltd | Comments |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| 510 (k) Number4 | The Lumilisse IPL
(Intense Pulsed
Light) Hair
Remover is an
over-the-counter
device
intended for the
removal of
unwanted hair. | K103184
Flash N Go is an
over the counter
device intended for
the removal of
unwanted hair.
Flash N Go is also
intended for
permanent
reduction in hair
regrowth defined
as long-term,
stable reduction in
hair counts
following a
treatment regime. | K131649
The mē Is an over-the-
counter device
Intended for the
removal of unwanted
hair. Mē Is also
Intended for
permanent reduction
In hair growth
following an Initial
treatment regimen
with or without
maintenance when
measured at 6, 9, and
12 months. | K160968
The iPulse
SmoothSkin Gold
Hair Removal System
is indicated for the
removal of
unwanted hair. The
iPulse Smoothskin
Gold is also indicated
for the permanent
reduction in hair
regrowth, defined as
the long-term, stable
reduction in the
number
of hairs regrowing
when measured at 6,
9 and 12 months
after the completion
of a
treatment regime. | Substantially
Equivalent |
| Indications for Use | | | | | |
| Use Environment | Home Use | Home Use | Home Use | Home Use | Substantially |
| | | | | | Equivalent |
| Wavelength | 550-1200 nm
(when using with
body lens)
600-1200 nm
(when using with
facial lens) | 475-1200 nm | 550-1200 nm | 510-1100nm | Different |
| Light Intensity | Level 1: 2.0 J/cm²
Level 2: 3.0 J/cm²
Level 3: 3.5 J/cm²
Level 4: 4.0 J/cm²
Level 5: 4.5 J/cm² | Level 1: 3-5 J/cm² | Maximum Optical
= 4 J/cm² | 3 - 6 J/cm² | Different |
| Repetition Rate | At Level 1, 1 pulse
every 1.6 seconds
At Level 5, 1 pulse
every 3.5 seconds | 1 pulse every 3.5 seconds | 1 pulse every 0.9 seconds | Manually, 1 pulse
every 1-2 seconds | Different |
| Power Source | 100-240 VAC, 3.5 A | 100-240V, 2A | 100-240 VAC, 50-60 Hz | 110V or 230V,
50/60Hz | Substantially
Equivalent |
| | | Temperature | | | |
| Operating | +10°C to +35°C | 10°C to 40°C | 10°C - 30° | 15°C - 30°C | Substantially |
| Storage | -40°C to +70°C | -40°C to +70°C | 10°C - 55°C | 85% non-condensing | Equivalent |
| | | Humidity | | | |
| Operating | 30% to 75% RH | 30% to 75% RH | Up to 80% at 37°C | N/A | Substantially |
| Storage | 30% to 75% RH | 30% to 90% RH | 90% at 55°C | N/A | Equivalent |
| | | Atmospheric Pressure | | | |
| Operating | 700 to 1060hPa | 700 to 1060hPa | 700-1060hPa | N/A | Substantially
Equivalent |
Predicate Product Comparison Table
6
7
Non-clinical Performance Data:
- ISO 10993-5 Biological Evaluation of Medical Devices – Part 5: Tests for In Vitro Cytotoxicity
- ISO 10993-10 Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Skin ● Sensitization
- . IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
- . IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: General Requirements for basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests
- . IEC 60601-1-11 Medical Electrical Equipment - Part 1-11: General Requirements for basic Safety and Essential Performance - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems used in the Home Healthcare Environment
- . IEC 60601-2-57 Medical electrical equipment - part 2-57: particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use.
- IEC 62471 Photobiological safety of lamps and lamp systems
- FCC Subpart 15B Unintentional Radiators
- . ISO 14971 Medical Devices – Applications of Risk Management to Medical Devices
- Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered a "Moderate" level of concern.
Usability Study
A Human Factors Usability study was conducted using 20 participants to demonstrate the participants were capable of reading the instruction manual and were then able to use the Lumilisse IPL Hair Remover correctly. The Conair Lumilisse IPL Hair Remover was found to be safe and effective for the intended users, uses and use environments based on the results of our simulated use study, biocompatibility testing,
Clinical Study:
A clinical study was conducted comparing the G920 and G930 IPL Hair Remover (European pre-cursor to the IPL960F Lumilisse Hair Remover) hand-held systems to evaluate the in-vivo efficacy and cutaneous acceptability on the legs and cutaneous acceptability for the underarms and half-upper lips.
Each of the two units had a significant effect in lowering the amount and density of hairs in regions tested. The only safety events appear to be unrelated to the units, themselves. The dermatological evaluation was positive for safety, and the final study results, for the large majority of the test Subjects, was that the units had the desired effects.
The comparative study concluded the Lumilisse Hair Remover reduction results last for 6 months with over 75% less hair on legs and concluded cutaneous acceptability for legs, underarms and half-upper lip.
8
The study concluded Lumilisse Hair Removal Systems as safe and effective when used according to instructions.
Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Conair concludes that the Lumilisse IPL Hair Removal System is substantially equivalent to predicate devices with regard to safety and effectiveness.