(196 days)
No
The summary describes a low-level laser device with automated and timed light distribution, controlled by an operating system. There is no mention of AI, ML, image processing, or any data-driven decision-making processes that would indicate the use of AI/ML technology. The performance studies focus on meeting design verification and validation criteria and substantial equivalence to predicate devices, not on AI/ML performance metrics.
Yes
The device is indicated for "Adjunctive use for the treatment of androgenic alopecia in females; the LX-100 is indicated to promote hair growth of females with androgenetic alopecia". The term "treatment" signifies a therapeutic purpose.
No
Explanation: The device description states its purpose is to "promote hair growth and provides adjunctive treatment" for a condition, not to diagnose it.
No
The device description explicitly states it is a "stationary low-level laser device" and mentions applying a "measured very high tolerance wavelength" to the scalp, indicating it is a hardware device that emits laser light.
Based on the provided information, the LX-100 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the treatment of androgenic alopecia and promotion of hair growth in females. This is a therapeutic use, not a diagnostic use.
- Device Description: The device is a low-level laser device that applies light to the scalp to stimulate hair growth. This is a physical intervention, not a test performed on biological samples in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on in vitro analysis.
The LX-100 is a therapeutic device that uses light energy to treat a medical condition.
N/A
Intended Use / Indications for Use
The LX-100 is a non-heating lamp as described under the provisions of 21 CFR §890.5500 and is indicated for: Adjunctive use for the treatment of androgenic alopecia in females; the LX-100 is indicated to promote hair growth of females with androgenetic alopecia who have Ludwig and Savin Hair Loss Scale classifications of I to II and who have been determined to have a Fitzpatrick Skin Typing of I to IV.
Product codes
OAP, NHN
Device Description
The LX-100 is a stationary low-level laser device that promotes hair growth and provides adjunctive treatment for androgenic (androgenetic) alopecia in females. The device provides automated and timed equal distribution of laser light to 100% of the scalp. The LX-100 operation is controlled by an operating system that affords the user maximum flexibility for individual treatments. The device applies a measured very high tolerance (≤+1%) wavelength (λ) to the scalp stimulating hair growth by the proven concept of biostimulation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Scalp
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use, Direction of Licensed Physician only
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)
The LX-100 Hair Growth Stimulation System met all of the specified acceptance criteria of the design verification and validation testing performed under design control and is found to be substantially equivalent to the currently marketed and approved predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection. The profiles are arranged in a way that creates a sense of depth and unity. Encircling the image is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 14, 2015
HairLabs International Incorporated Mr. James Britt President 742 Harpeth Knoll Road Nashville, Tennessee 37221
Re: K142824
Trade Name: LX-100 Hair Growth Stimulation System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: OAP, NHN Dated: September 25, 2014 Received: September 30, 2014
Dear Mr. Britt:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers, International and Consumer Assistance 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
Concurrence & Template History Page [THIS PAGE IS INCLUDED IN IMAGE COPY ONLY]
Full Submission Number:
For Office of Compliance Contact Information:
http://insideportlets.fda.gov:9010/portal/page?_pageid=197,415881&_dad=portal&_schema=PORTAL&org=318
For Office of Surveillance and Biometrics Contact Information:
http://insideportlets.fda.gov:9010/portal/page? pageid=197,415881& dad=portal& schema=PORTAL&org=423
| Digital Signature Concurrence Table | |
|---|---|
| Reviewer Sign-Off | |
| Branch Chief Sign-Off | |
| Division Sign-Off |
Template Name: K1(A) – SE after 1996
Template History:
| Date of Update | By | Description of Update |
|---|---|---|
| 7/27/09 | Brandi Stuart | Added Updates to Boiler Table |
| 8/7/09 | Brandi Stuart | Updated HFZ Table |
| 1/11/10 | Diane Garcia | Liability/Warranty sentence added at bottom of 1st page |
| 10/4/11 | M. McCabe Janicki | Removed IFU sheet and placed in Forms |
| 9/25/12 | Edwena Jones | Added digital signature format |
| 12/12/12 | M. McCabe Janicki | Added an extra line between letter signature block and the word |
| "Enclosure". Also, added a missing digit in 4-digit extension on | ||
| letterhead zip code: "002" should be "0002". | ||
| 4/2/2013 | M. McCabe Janicki | Edited sentence that starts "If you desire specific advice for your |
| device on our labeling regulation (21 CFR Part 801)." Replaced | ||
| broken Compliance link with general link to DSMICA. | ||
| 4/12/2013 | Margaret McCabe | |
| Janicki | Fixed a typo: Paragraph 1, final sentence, "We remind you, | |
| however; that device labeling must be truthful." Replaced | ||
| incorrect semicolon with a comma. |
3
Indications for Use
510(k) Number (if known) K142824
Device Name
LX-100 Hair Growth Stimulation System
Indications for Use (Describe)
The LX-100 is a non-heating lamp as described under the provisions of 21 CFR §890.5500 and is indicated for:
Adjunctive use for the treatment of androgenic alopecia in females; the LX-100 is indicated to promote hair growth of females with androgenetic alopecia who have Ludwig and Savin Hair Loss Scale classifications of I to II and who have been determined to have a Fitzpatrick Skin Typing of I to IV.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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."
4
HairLabs International Inc.
510(k) Summary
(as required per 21 CFR: §807.92)
LX-100 Hair Growth Stimulation System
-
l. Applicant: Hairlabs International, Incorporated 742 Harpeth Knoll Road Nashville, TN 37221
Phone: (615)-646-9537 -
II. Contact Name: James Britt, President james@hairlabs.com
III. Device Name:
| Proprietary Name | LX-100 Hair Growth Stimulation System |
|---|---|
| Common/Usual Name | Light Therapy Hair System |
| Classification Name | Infrared Lamp per 21CFR 890.5500 |
Product Code(s)............................................................... OAP
IV. Predicate Devices And Comparison
| Predicate Device
Comparative Item | Hairlabs
International
LX-100 | Midwest RF
MEP-90 | Theradome Inc.
LH80 Pro |
|-----------------------------------------|---------------------------------------------|---------------------------------------------|----------------------------|
| 501(k) Number | K142824 | K091496 | K122950 |
| Device Name | LX-100 Hair
Growth Stimulation
System | MEP-90 Hair
Growth Stimulation
System | Laser Helmet LH80
PRO |
| Manufacture | Hairlabs
International, Inc. | Midwest RF, LLC | Theradome, Inc. |
| Establishment
Registration
Number | N/A | 2134565 | Unknown |
| Device
Regulation
Description | Infrared Lamp | Infrared Lamp | Infrared Lamp |
| Device
Regulation
Number | 21CFR; §890.5500 | 21CFR; §890.5500 | 21CFR; §890.5500 |
| Device | A device that emits | A device that emits | A device that emits |
5
| Regulation
Identification/
Classification | energy at infrared
frequencies
(approximately 700
nanometers to
50,000 nanometers
to provide topical
heating. | energy at infrared
frequencies
(approximately 700
nanometers to
50,000 nanometers
to provide topical
heating. | energy at infrared
frequencies
(approximately 700
nanometers to
50,000 nanometers
to provide topical
heating. |
|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Physical State | Light emitting
stimulator | Light emitting
stimulator | Light emitting
stimulator |
| Product
Nomenclature | Lamp, infrared | Lamp, infrared | Lamp, infrared |
| Product Code | OAP | OAP | OAP |
| Device Class | Class 2 | Class 2 | Class 2 |
| 21CFR Part 1010
Laser
Classification/
Compliance | Illa; IIIr
Full Compliance | Illa; IIIr
Full Compliance | Illa; IIIr |
| FDA Device Risk
Classification | Non-significant
(NSR) | Non-significant
(NSR) | Non-significant
(NSR) |
| Wavelength (λ) | 650nm (+/-1%)
644nm to 656nm
Measured | 650nm (+/-1%)
644nm to 656nm
Measured | 678nm center
wavelength
Published |
| Output Per Diode
in mw | ≤4.5mW Measured | ≤4.5mW Measured | ≤5mW
Unpublished |
| Treatment Area in
cm2 | 1065.10 cm2
Mathematically
derived | 990.80 cm2
Mathematically
derived | 990.80 cm2
Mathematically
derived |
| Total Output for
Treatment Area,
Dosage mW/cm2 | .3802 mW/cm2
Mathematically
Derived | .3724 mW/cm2
Mathematically
Derived | .4037 mW/cm2
Mathematically
Derived |
| Recommended
Treatment
Regimen | 2 - 20 Minute
Treatments Per
Week, On Non-
consecutive Days
for 26 Weeks for a
Total of 52
Treatments | 2 - 20 Minute
Treatments Per
Week, On Non-
consecutive Days
for 18 Weeks for a
Total of 36
Treatments | 2 - 20 Minute
Treatments Per
Week, On Non-
consecutive Days
for 26 Weeks for a
Total of 52
Treatments |
| Fluence, 20
Minute Treatment
J/cm2 | .45629 J/cm2
Mathematically
derived | .44691 J/cm2
Mathematically
derived | .48446 J/cm2
Mathematically
Derived |
| Number of Lasers | 90 | 82 | 80 |
| Laser Pulse Rate | Continuous | Continuous | Continuous |
| Laser Pulse
Duration | Continuous | Continuous | Continuous |
| Power | 3Volts DC;
110 Volts AC
converted to
24 Volts DC | 3 Volts DC:
110 Volts AC
converted to
24 Volts DC | Unknown
proprietary |
6
| Aiming Beam | No lens; diffused beam, fixed coverage | No lens; diffused beam, fixed coverage | No lens, diffused beam, fixed coverage |
|---|---|---|---|
| Laser Beam Scattering Outside Aperture | None - Fixed angulation and required beam interruption prevent beam scattering outside of Helmet assembly | None - Fixed angulation and required beam interruption prevent beam scattering outside of Helmet assembly | None when patient is in helmet. |
| Output Mode | Direct Light | Direct Light | Direct Light |
| Sterilization | Basic cleaning, Instructions provided; No sterilization claimed, called for or possible | Basic cleaning, Instructions provided; No sterilization claimed, called for or possible | No sterilization claimed or called for in published materials |
| Device Type | Free standing, movable laser helmut, spherical laser helmet | Free standing, movable laser helmet, spherical laser helmet | Portable helmet only, sits on patients head, spherical laser helmet |
| Accessories | None; all items described are necessary for basic operation including safety keys for key lock, 10' medical grade power cord, operation manual and 2 pair laser safety glasses | None; all items described are necessary for basic operation including mouse, keyboard, monitor, safety keys for key lock, 10' medical grade power cord, operation manual and 2 pair laser safety glasses | None; all items described are necessary for basic operation including wall charger |
7
| Materials | Injection molded
and painted
polycarbonate and
polystyrene,
Molded and
painted fiberglass.
All paint is two part
epoxy based. | Injection molded
and painted
polycarbonate and
polystyrene,
Molded and
painted fiberglass.
All paint is two part
epoxy based. | Unkown and would
be proprietary
information under
18U.S.C.§1832-
Assumed no
issues due to
issuance of 510(k) | Unknown and
would be
proprietary
information under
18U.S.C§1832-
Assumed no
issues due to
issuance of 510(k) |
|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | There are no new
materials in use on
this device that are
not in routine use
on other devices.
The
biocompatibility is
comparable to any
of the legally
marketed devices
listed as follows:
Midwest RF
K091496
Model MEP-90
Sunetics
International
K132646
Model Clinical
Laser G
Theradome, Inc
K122950
Model LH80 PRO | Assumed no
issues due to
issuance of 510(k) | Assumed no
issues due to
issuance of 510(k) | Assumed no
issues due to
issuance of 510(k) |
| Indications of Use | LX-100 is for
adjunctive use for
the treatment of
androgenic
(androgenetic)
alopecia in females
and is indicated to
promote hair
growth of females
with androgenic
(androgenetic)
alopecia who have
Ludwig and Savin
Hair Loss Scale
classifications of I
to II and who have
been determined to
have a Fitzpatrick
Skin Typing of I to
IV | MEP-90 is for
adjunctive use for
the treatment of
androgenic
(androgenetic)
alopecia in females
and is indicated to
promote hair
growth of females
with androgenic
(androgenetic)
alopecia who have
Ludwig and Savin
Hair Loss Scale
classifications of I
to II and who have
been determined to
have a Fitzpatrick
Skin Typing of I to
IV | Laser Helmet LH80
PRO is an over the
counter (OTC)
device indicated to
treat androgenic
alopecia, to
promote hair
growth in females
with female pattern
hair loss (FPHL) on
the Ludwig and
Savin Hair Loss
Scale I-II,
Fitzpatrick Skin-
Types I to IV | |
| Indications of Use
Source | Prescription | Prescription | Over The Counter | |
| Indications of Use
Sale and Usage
Restrictions | Direction of
Licensed Physician
only | Direction of
Licensed Physician
only | Over The Counter | |
| Indications of Use
Installation | Certified on site | Certified on site | Drop shipped to
user | |
| Indications of Use
Operator and
User Training /
Education | Factory and/or on
site training at
installation;
Internet access for
Operations Manual | Factory and/or on
site training (User
option) of
approximately 6-8
hours at
installation;
Internet access for
operational
updates; Operation
Manual; Continuing
education program
TBD | Operation manual | |
| Indications of Use
Operation Control
and Length of
Treatment | Default settings for
recommended
treatment protocol;
Operator resets of
time and dosage
which is controlled
by computer | Default settings for
recommended
treatment protocol;
Operator resets of
time and dosage
which is controlled
by computer | Single button
control, button
push starts one 20
minute cycle, unit
turns off when
cycle ends | |
| Indications of Use
Safety In
Operation | Warning labels on
device; key lock
with on screen
warning; default
treatment settings;
fixed maximum
power output
regardless of
settings; constant
thru beam interrupt
by patient required
for laser operation;
warning on screen
to insure operator
and patient are
wearing safty
glasses before
lasers will operate;
no beam scatter
outside of helmet
assembly; tilting of
head no ≥3/8"
interrupt | Warning labels on
device; key lock
with on screen
warning; default
treatment settings;
fixed maximum
power output
regardless of
settings; constant
thru beam interrupt
by patient required
for laser operation;
warning on screen
to insure operator
and patient are
wearing safty
glasses before
lasers will operate;
no beam scatter
outside of helmet
assembly; tilting of
head no ≥3/8"
interrupt; head
proximity safety
circuitry | Unknown -
proprietary | |
8
9
V. Indications For Use
The LX-100 is a non-heating lamp as described under the provisions of 21 CFR §890.5500 and is indicated for:
Adjunctive use for the treatment of androgenic alopecia in females; the LX-100 is indicated to promote hair growth of females with androgenetic alopecia who have Ludwig and Savin Hair Loss Scale classifications of I to II and who have been determined to have a Fitzpatrick Skin Typing of I to IV
VI. Technological Characteristics
The LX-100 is a stationary low-level laser device that promotes hair growth and provides adjunctive treatment for androgenic (androgenetic) alopecia in females. The device provides automated and timed equal distribution of laser light to 100% of the scalp.
The LX-100 operation is controlled by an operating system that affords the user maximum flexibility for individual treatments. The device applies a measured very high tolerance (≤+1%) wavelength (λ) to the scalp stimulating hair growth by the proven concept of biostimulation.
10
Performance Data and Clinical Efficacy
The LX-100 Hair Growth Stimulation System met all of the specified acceptance criteria of the design verification and validation testing performed under design control and is found to be substantially equivalent to the currently marketed and approved predicate devices.
VII. Conclusion
The LX-100 is substantially equivalent to other pulsed therapeutic light therapy svstems currently in commercial distribution. The LX-100 has the same intended use and technological and safety characteristics to the predicate devices approved for commercial distribution under 510(k) number K091496, and K122950.
It equals the clinically accepted therapeutic results standards of FDA 510(k) K091496, and K122950 previously approved light therapy systems.
The technological equivalence to the predicate devices is substantiated by the wavelength, power output and dosage generated by the LX-100. The LX-100 provides expanded treatment benefits and regimens for clinical presentations already approved by the Food and Drug Administration for the predicate device.
The LX-100 is as safe and effective as a combination of the predicate devices listed and numerous others. It has the same intended use of affecting hair growth as the hair growth predicate device (K091496, and K122950). In addition, the LX-100 has the same general indications, i.e., treating androgenic alopecia, and the same specific indication of promoting hair growth as the predicate device.
The LX-100 also has many of the same or similar technological characteristics as a combination of its predicate devices. These include multiple lasers and visible laser wavelength.