(196 days)
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
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.
The provided text is a 510(k) summary for the LX-100 Hair Growth Stimulation System. It focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a detailed study proving the device meets them in the way a clinical trial report would.
Here's an analysis based on the provided document, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list "acceptance criteria" for clinical performance. Instead, it demonstrates technological equivalence to predicate devices in terms of physical characteristics and clinical equivalence based on the predicate devices having already met therapeutic results standards.
| Feature/Characteristic | Predicate Device (K091496 or K122950) Performance (Implied Acceptance Criteria) | LX-100 Hair Growth Stimulation System Performance |
|---|---|---|
| Wavelength (λ) | 650nm (+/-1%) (K091496) or 678nm center (K122950) | 650nm (+/-1%) (644nm to 656nm Measured) |
| Output Per Diode | ≤4.5mW (K091496) or ≤5mW (K122950) | ≤4.5mW Measured |
| Total Output/Dosage (mW/cm2) | .3724 mW/cm2 (K091496) or .4037 mW/cm2 (K122950) | .3802 mW/cm2 |
| Fluence (J/cm2) | .44691 J/cm2 (K091496) or .48446 J/cm2 (K122950) | .45629 J/cm2 |
| Treatment Regimen | 2 - 20 Minute Treatments Per Week, On Non-consecutive Days for 18 or 26 Weeks | 2 - 20 Minute Treatments Per Week, On Non-consecutive Days for 26 Weeks |
| Number of Lasers | 82 (K091496) or 80 (K122950) | 90 |
| Indications for Use | For adjunctive use for the treatment of androgenic (androgenetic) alopecia in females; indicated to promote hair growth of females with Ludwig and Savin Hair Loss Scale classifications of I to II and Fitzpatrick Skin Typing of I to IV | Same as predicate devices, but for 26 weeks. |
| Safety | Compliance with laser safety regulations (Class Illa; IIIr) and safety features (key lock, interlock, head proximity safety). | Full Compliance (Class Illa; IIIr) and similar safety features. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a new clinical study. It relies on the equivalence to previously approved devices. Therefore, there is no "test set" in the sense of a new patient cohort for the LX-100. The performance is based on the established performance of the predicate devices. There is no specific data provenance mentioned in terms of country of origin or retrospective/prospective for a study of the LX-100 itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as no new clinical study to establish performance for the LX-100 is presented. The "ground truth" for the efficacy of low-level laser therapy for androgenetic alopecia in females is implied to have been established by the predicate devices' approval through their own studies.
4. Adjudication Method for the Test Set
Not applicable as no new clinical study to establish performance for the LX-100 is presented.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This type of study is not described or implied in the document, as it focuses on demonstrating substantial equivalence based on technological and intended use similarities to existing devices, not on comparing performance with and without AI assistance or human reader improvement.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable to the LX-100, as it is a physical medical device (a hair growth stimulation system) and not an AI algorithm. Its performance is inherent to its physical operation and biological effect, not an algorithmic output requiring standalone evaluation.
7. The Type of Ground Truth Used
For the LX-100, the "ground truth" for its acceptance is based on its substantial equivalence to existing legally marketed predicate devices. The efficacy and safety claims of low-level laser therapy for androgenetic alopecia in females, which the LX-100 aims to meet, were presumably established by the predicate devices through clinical trials (pathology, clinical observable outcomes, or other relevant data for hair growth). The current document does not detail the specific ground truth used in those predicate studies.
8. The Sample Size for the Training Set
Not applicable. The LX-100 is a hardware device; it does not utilize a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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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
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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
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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 onletterhead zip code: "002" should be "0002". |
| 4/2/2013 | M. McCabe Janicki | Edited sentence that starts "If you desire specific advice for yourdevice on our labeling regulation (21 CFR Part 801)." Replacedbroken Compliance link with general link to DSMICA. |
| 4/12/2013 | Margaret McCabeJanicki | Fixed a typo: Paragraph 1, final sentence, "We remind you,however; that device labeling must be truthful." Replacedincorrect semicolon with a comma. |
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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)
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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 DeviceComparative Item | HairlabsInternationalLX-100 | Midwest RFMEP-90 | Theradome Inc.LH80 Pro |
|---|---|---|---|
| 501(k) Number | K142824 | K091496 | K122950 |
| Device Name | LX-100 HairGrowth StimulationSystem | MEP-90 HairGrowth StimulationSystem | Laser Helmet LH80PRO |
| Manufacture | HairlabsInternational, Inc. | Midwest RF, LLC | Theradome, Inc. |
| EstablishmentRegistrationNumber | N/A | 2134565 | Unknown |
| DeviceRegulationDescription | Infrared Lamp | Infrared Lamp | Infrared Lamp |
| DeviceRegulationNumber | 21CFR; §890.5500 | 21CFR; §890.5500 | 21CFR; §890.5500 |
| Device | A device that emits | A device that emits | A device that emits |
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| RegulationIdentification/Classification | energy at infraredfrequencies(approximately 700nanometers to50,000 nanometersto provide topicalheating. | energy at infraredfrequencies(approximately 700nanometers to50,000 nanometersto provide topicalheating. | energy at infraredfrequencies(approximately 700nanometers to50,000 nanometersto provide topicalheating. |
|---|---|---|---|
| Physical State | Light emittingstimulator | Light emittingstimulator | Light emittingstimulator |
| ProductNomenclature | Lamp, infrared | Lamp, infrared | Lamp, infrared |
| Product Code | OAP | OAP | OAP |
| Device Class | Class 2 | Class 2 | Class 2 |
| 21CFR Part 1010LaserClassification/Compliance | Illa; IIIrFull Compliance | Illa; IIIrFull Compliance | Illa; IIIr |
| FDA Device RiskClassification | Non-significant(NSR) | Non-significant(NSR) | Non-significant(NSR) |
| Wavelength (λ) | 650nm (+/-1%)644nm to 656nmMeasured | 650nm (+/-1%)644nm to 656nmMeasured | 678nm centerwavelengthPublished |
| Output Per Diodein mw | ≤4.5mW Measured | ≤4.5mW Measured | ≤5mWUnpublished |
| Treatment Area incm2 | 1065.10 cm2Mathematicallyderived | 990.80 cm2Mathematicallyderived | 990.80 cm2Mathematicallyderived |
| Total Output forTreatment Area,Dosage mW/cm2 | .3802 mW/cm2MathematicallyDerived | .3724 mW/cm2MathematicallyDerived | .4037 mW/cm2MathematicallyDerived |
| RecommendedTreatmentRegimen | 2 - 20 MinuteTreatments PerWeek, On Non-consecutive Daysfor 26 Weeks for aTotal of 52Treatments | 2 - 20 MinuteTreatments PerWeek, On Non-consecutive Daysfor 18 Weeks for aTotal of 36Treatments | 2 - 20 MinuteTreatments PerWeek, On Non-consecutive Daysfor 26 Weeks for aTotal of 52Treatments |
| Fluence, 20Minute TreatmentJ/cm2 | .45629 J/cm2Mathematicallyderived | .44691 J/cm2Mathematicallyderived | .48446 J/cm2MathematicallyDerived |
| Number of Lasers | 90 | 82 | 80 |
| Laser Pulse Rate | Continuous | Continuous | Continuous |
| Laser PulseDuration | Continuous | Continuous | Continuous |
| Power | 3Volts DC;110 Volts ACconverted to24 Volts DC | 3 Volts DC:110 Volts ACconverted to24 Volts DC | Unknownproprietary |
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| 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 |
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| Materials | Injection moldedand paintedpolycarbonate andpolystyrene,Molded andpainted fiberglass.All paint is two partepoxy based. | Injection moldedand paintedpolycarbonate andpolystyrene,Molded andpainted fiberglass.All paint is two partepoxy based. | Unkown and wouldbe proprietaryinformation under18U.S.C.§1832-Assumed noissues due toissuance of 510(k) | Unknown andwould beproprietaryinformation under18U.S.C§1832-Assumed noissues due toissuance of 510(k) |
|---|---|---|---|---|
| Biocompatibility | There are no newmaterials in use onthis device that arenot in routine useon other devices.Thebiocompatibility iscomparable to anyof the legallymarketed deviceslisted as follows:Midwest RFK091496Model MEP-90SuneticsInternationalK132646Model ClinicalLaser GTheradome, IncK122950Model LH80 PRO | Assumed noissues due toissuance of 510(k) | Assumed noissues due toissuance of 510(k) | Assumed noissues due toissuance of 510(k) |
| Indications of Use | LX-100 is foradjunctive use forthe treatment ofandrogenic(androgenetic)alopecia in femalesand is indicated topromote hairgrowth of femaleswith androgenic(androgenetic)alopecia who haveLudwig and SavinHair Loss Scaleclassifications of Ito II and who havebeen determined tohave a FitzpatrickSkin Typing of I toIV | MEP-90 is foradjunctive use forthe treatment ofandrogenic(androgenetic)alopecia in femalesand is indicated topromote hairgrowth of femaleswith androgenic(androgenetic)alopecia who haveLudwig and SavinHair Loss Scaleclassifications of Ito II and who havebeen determined tohave a FitzpatrickSkin Typing of I toIV | Laser Helmet LH80PRO is an over thecounter (OTC)device indicated totreat androgenicalopecia, topromote hairgrowth in femaleswith female patternhair loss (FPHL) onthe Ludwig andSavin Hair LossScale I-II,Fitzpatrick Skin-Types I to IV | |
| Indications of UseSource | Prescription | Prescription | Over The Counter | |
| Indications of UseSale and UsageRestrictions | Direction ofLicensed Physicianonly | Direction ofLicensed Physicianonly | Over The Counter | |
| Indications of UseInstallation | Certified on site | Certified on site | Drop shipped touser | |
| Indications of UseOperator andUser Training /Education | Factory and/or onsite training atinstallation;Internet access forOperations Manual | Factory and/or onsite training (Useroption) ofapproximately 6-8hours atinstallation;Internet access foroperationalupdates; OperationManual; Continuingeducation programTBD | Operation manual | |
| Indications of UseOperation Controland Length ofTreatment | Default settings forrecommendedtreatment protocol;Operator resets oftime and dosagewhich is controlledby computer | Default settings forrecommendedtreatment protocol;Operator resets oftime and dosagewhich is controlledby computer | Single buttoncontrol, buttonpush starts one 20minute cycle, unitturns off whencycle ends | |
| Indications of UseSafety InOperation | Warning labels ondevice; key lockwith on screenwarning; defaulttreatment settings;fixed maximumpower outputregardless ofsettings; constantthru beam interruptby patient requiredfor laser operation;warning on screento insure operatorand patient arewearing saftyglasses beforelasers will operate;no beam scatteroutside of helmetassembly; tilting ofhead no ≥3/8"interrupt | Warning labels ondevice; key lockwith on screenwarning; defaulttreatment settings;fixed maximumpower outputregardless ofsettings; constantthru beam interruptby patient requiredfor laser operation;warning on screento insure operatorand patient arewearing saftyglasses beforelasers will operate;no beam scatteroutside of helmetassembly; tilting ofhead no ≥3/8"interrupt; headproximity safetycircuitry | Unknown -proprietary |
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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.
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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.
§ 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.