(82 days)
The Capillus272 Pro, Capillus82 OfficePro, Capillus202 are intended for the promotion of hair growth in females with androgenic alopecia who have Ludwig-Savin Classifications I- II, and in males with androgenic alopecia who have Norwood Hamilton Classifications IIa-V ; and both genders having Fitzpatrick Classification of Skin Phototypes I to IV.
The Capillus272 Pro and Capillus272 OfficePro both consist of 272 red, visible light, diode lasers operating at 650 nanometers, configured within an outer helmet and protective inner, and configured for portable use with rechargeable battery and adapter (capillus272 Pro) and clinical office use (Capillus272 OfficePro). The Capillus82 and Capillus202 are exactly the same as the Capillus272 Pro with the exception of the number of diodes which are 82 and 202 respectively. As stated in prior submissions, the devices emit an audible tone at the beginning and end of a therapy session, indicating that therapy has begun (2 short beeps) or ended (one long beep). The portable systems are powered by rechargeable Li-Ion battery cells assembled into a proprietary battery pack. Both the battery are fully compliant to recognized, international standards. The OfficePro is directly powered by the DC charger, which is fully compliant to recognized, international standards.
The provided text is a 510(k) summary for medical devices (Capillus272 Pro, Capillus272 OfficePro, Capillus82, and Capillus202) intended for hair growth promotion. It does not contain a detailed report of a study with specific acceptance criteria and performance data in the format typically used for diagnostic or AI-based devices. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and the general understanding of Low-Level Laser/Light Therapy (LLLT) efficacy.
However, I can extract the relevant information from the document to construct an answer based on the intent of your questions, even if some points are addressed by referencing prior submissions or common knowledge about LLLT.
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria related to efficacy (e.g., specific percentage increase in hair count) for this specific submission. Instead, it relies on the established efficacy of LLLT for androgenic alopecia and compliance with safety standards.
| Acceptance Criterion (Implicit) | Reported Device Performance (Referenced) |
|---|---|
| Safety: Compliance with recognized international standards for laser safety. | The Capillus272 OfficePro, Capillus82, and Capillus202 conform to the standard IEC-602825-2007-03. This establishes the AEL (accessible emission limits) as 5 milliWatts maximum for Class 3R lasers. The charger conforms to IEC 60950. The devices are classified as Class 3R laser systems. "There have been no reported safety issues with any LLLT device to date." "All compliant LLLT systems which use red light diode lasers are classified as class 3R laser systems according to the IEC standard for allowable emission levels, which is a recognized standard by the FDA as well, and the adverse event profile is the same." "no new safety or efficacy concerns are raised due to the minor differences present between devices." |
| Efficacy (Substantial Equivalence): Promotion of hair growth in specified populations, comparable to predicate devices. | The document asserts that "Capillus is certain that the difference in the physical appearance, number of diodes, or in the method of delivering the radiant energy of the systems is of no consequence and does not affect the therapeutic value or the safety profile." It explicitly states that "The Capillus272 Pro, Capillus82 and Capillus82 and Capillus202 are as safe and effective as the predicate devices, iGrow and HairMax LaserBand, as well as other reference devices in its class, such as the Hairmax LaserComb." The comparative table lists "Efficacy Rates - High Compared to Placebo" for Capillus devices, referencing "Efficacy Rates - 34-41%" for iGrow and "Trial results are all significant increase with respect to placebo" for HairMax LaserBand. It also states, "the FDA has acknowledged that Low-Level Laser/Light Therapy is a viable modality for treating androgenic alopecia in both genders". The expansion of use for males is considered "reasonable and consistent with the known uses attributed to LLLT devices in general" given iGrow demonstrated equivalence between genders and HairMax proved the non-gender-bias concept. |
| Performance Data: Compliance with design specifications. | "Performance testing was conducted to confirm compliance to design specifications; all functions have been verified to operate as designed. All acceptance criteria were met by the device." (Note: This is a general statement and not specific quantitative performance data for hair growth). |
2. Sample size used for the test set and the data provenance
The document does not describe a new clinical study with a "test set" for this specific 510(k) submission. The submission relies on the established efficacy of LLLT devices in general and predicate devices. Therefore, there is no information on a specific sample size or data provenance (country, retrospective/prospective) for a new test set in this document. The efficacy claims are derived from prior studies of predicate and reference devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As no new clinical study with a "test set" is detailed in this submission, there is no mention of experts forming a ground truth for such a set. The overall acceptance of LLLT as a viable modality is based on broader scientific consensus and regulatory approvals.
4. Adjudication method for the test set
Not applicable, for the same reasons as #3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a low-level laser therapy device for hair growth, not an AI-based diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI system.
7. The type of ground truth used
The "ground truth" for the device's intended effect (hair growth promotion) is based on:
- Clinical trial results of predicate and reference devices: The document refers to efficacy rates (e.g., 34-41% increase compared to placebo for iGrow, significant increase for HairMax LaserBand) from studies supporting the clearance of those devices.
- Scientific and Medical Consensus: The statement "the FDA has acknowledged that Low-Level Laser/Light Therapy is a viable modality for treating androgenic alopecia" implies a broader acceptance based on accumulated evidence.
- Absence of reported adverse events: "There have been no reported safety issues with any LLLT device to date."
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set. The "training" in this context would be the cumulative clinical evidence for LLLT technology.
9. How the ground truth for the training set was established
Not applicable. For the reasons stated in #8.
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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle with three human profiles incorporated into its design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 25, 2016
Capillus, LLC Ms. Patricia Schnoor Director, Quality, Safety, & Compliance Manager 1715 NW 82nd Ave Miami, Florida 33126
Re: K160285
Trade/Device Name: Capillus272 Pro. Capillus272 Officepro. Capillus82, Capillus202 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: February 1, 2016 Received: February 3, 2016
Dear Ms. Schnoor:
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 devicerelated 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.
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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/ResourcesforYou/Industry/default.htm. 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.
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 -A
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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Indications for Use
510(k) Number (if known) K160285
Device Name
Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202
Indications for Use (Describe)
The Capillus272 Pro, Capillus82 OfficePro, Capillus202 are intended for the promotion of hair growth in females with androgenic alopecia who have Ludwig-Savin Classifications I- II, and in males with androgenic alopecia who have Norwood Hamilton Classifications IIa-V ; and both genders having Fitzpatrick Classification of Skin Phototypes I to IV.
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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510(k) Summary
Capillus, LLC
Date Prepared:
February 01, 2016
Submitter's Contact Information:
| Name: | Patricia Schnoor |
|---|---|
| Address: | Capillus LLC1715 NW 82nd AvenueMiami, FL 33126 |
| EstablishmentRegistration# | 3010123655 |
| Telephone: | (786) 888-1874 |
| Facsimile: | (305) 418-7581 |
Name of Device and Name / Address of Sponsor:
| Trade Name: | Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202 | |
|---|---|---|
| Common or Usual Name: | Lamp, non-heating, for promotion of hair growth | |
| Classification Name: | Infrared lamp per 21 CFR 890.5500 | |
| Classification Code: | OAP (Laser, Comb, Hair) | |
| Sponsor Contact Information: | Patricia SchnoorCapillus LLC1715 NW 82nd AvenueMiami, FL 33126 | |
| Telephone: | (786) 888-1874 |
Predicate Devices:
| Device Trade Name | Manufacturer | 510(k) |
|---|---|---|
| iGrow II | Apira | 122248, 140931 |
| HairMax LaserBand | Lexington International | 142573 |
Reference Devices:
| Device Trade Name | Manufacturer |
|---|---|
| Hairmax LaserComb | Lexington International |
Intended Use / Indications for Use:
Capillus272 Pro, Capillus272 OfficePro, Capillus82, and Capillus202 are intended for the promotion of hair growth in females with androgenic alopecia who have Ludwig-Savin Classifications I – II, and in males with androgenetic alopecia who have Norwood Hamilton Classifications IIa-V; and both genders having Fitzpatrick Classification of Skin Phototypes I-IV.
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Technological Characteristics
The Capillus272 Pro and Capillus272 OfficePro both consist of 272 red, visible light, diode lasers operating at 650 nanometers, configured within an outer helmet and protective inner, and configured for portable use with rechargeable battery and adapter (capillus272 Pro) and clinical office use (Capillus272 OfficePro). The Capillus82 and Capillus202 are exactly the same as the Capillus272 Pro with the exception of the number of diodes which are 82 and 202 respectively.
As stated in prior submissions, the devices emit an audible tone at the beginning and end of a therapy session, indicating that therapy has begun (2 short beeps) or ended (one long beep). The portable systems are powered by rechargeable Li-Ion battery cells assembled into a proprietary battery pack. Both the battery are fully compliant to recognized, international standards. The OfficePro is directly powered by the DC charger, which is fully compliant to recognized, international standards.
Performance Data:
Performance testing was conducted to confirm compliance to design specifications; all functions have been verified to operate as designed. All acceptance criteria were met by the device. The Capillus272 OfficePro, Capillus82, and Capillus202 conform to the standard IEC-602825-2007-03. This IEC standard is a recognized and accepted standard by the FDA. The guidance document for this accepted standard is found in the Federal register, July 26, 2001 (volume 66, Number 144) [page 39049 39050]. This report validates for the Capillus272 Pro, Capillus272 OfficePro, Capillus202 the laser class of 3R which establishes the AEL (accessible emission limits) as 5 milliWatts maximum. The charger conforms to IEC 60950.
With regard to all Capillus models and reference devices, there are no reported adverse events for this technology.
Substantial Equivalence
The Capillus family of devices referenced in this application are the same technology used by the other LLLT devices cleared under device code OAP. The Capillus272 Pro, Capillus82 and Capillus82 and Capillus202 are as safe and effective as the predicate devices, iGrow and HairMax LaserBand, as well as other reference devices in its class, such as the Hairmax LaserComb. The Hairmax LaserComb, offered as a reference, is proof of the functionality and acceptability of the first device to be cleared by the FDA in the category of OAP, both technically and clinically.
Capillus is certain that the difference in the physical appearance, number of diodes, or in the method of delivering the radiant energy of the systems is of no consequence and does not affect the therapeutic value or the safety profile. All compliant LLLT systems which use red light diode lasers are classified as class 3R laser systems according to the IEC standard for allowable emission levels, which is a recognized standard by the FDA as well, and the adverse event profile is the same.
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| Capillus Devices | iGrow | HairMax LaserBand |
|---|---|---|
| K143199; K150578; K151516; K153618 | K122248; K140931 | K142573 |
| LLLT Device Type | LLLT Device Type | LLLT Device Type |
| Prescription Use | Prescription Use | OTC |
| Intended Use - Androgenic Alopecia | Intended Use - Androgenic Alopecia | Intended Use - Androgenic Alopecia |
| Contain Laser Diodes- Class 3R | Contain Laser Diodes- Class 3R and LEDs | Contain Laser Diodes- Class 3R |
| Helmet/Cap Design | Helmet/Cap Design | Hair band, move over scalp |
| 650nm | 650nm | 655nm |
| Marketing clearance for Females | Marketing clearance for Males and Females | Marketing clearance for both genders |
| Passive Use-Hands Free | Passive Use-Hands Free | Passive Use-Hands-Free + user placement |
| 272 Laser Diodes | 21 Laser Diodes; 30 LEDs | 82 (3 positions) = 246 laser diodes |
| OAP Classification | OAP Classification | OAP Classification |
| Classification Name -Infrared Lamp | Classification Name -Infrared Lamp | Classification Name - Infrared Lamp |
| Common Usage Name - Lamp, Non-Heating | Common Usage Name - Lamp, Non-Heating | Common Usage Name - Lamp, Non-Heating |
| General & Plastic Surgery Committee | General & Plastic Surgery Committee | General & Plastic Surgery Committee |
| Fitzpatrick Skin Phototypes - I-IV | Fitzpatrick Skin Phototypes - I-IV | Fitzpatrick Skin Phototypes - I-IV |
| Ludwig-Savin I-II (females) | Ludwig-Savin I-II (females) | Ludwig-Savin I-II (females); NorwoodHamilton IIA-V (males); or both |
| Efficacy Rates - High Compared to Placebo | Efficacy Rates - 34-41% | Trial results are all significant increase withrespect to placebo. |
| Treatment- 17 weeks, every other day(indefinite) | Treatment- 17 weeks, every other day(indefinite) | Treatment - ~16 weeks, every other day(indefinite) |
| Device Class II | Device Class II | Device Class II |
Based on technology, therapy outcome, similar design, wavelength choice, and treatment session time (all substantially equivalent), the expansion of the use for males (as indicated in the iGrow) from one device to its equivalent is reasonable and consistent with the known uses attributed to LLLT devices in general. The iGrow device demonstrated equivalence between genders with 21 diodes and HairMax proved the non-gender-bias concept with the equivalent of 246 diodes. There have been no reported safety issues with any LLLT device to date. It is therefore established that there is no difference between the devices, the regimens, or the technology; and the number of diodes does not adversely affect the safety of the devices.
Thus, Capillus claims the indications for use (all Capillus devices) should apply as stated: The Capillus272 Pro, Capillus272 OfficePro, Capillus22, and Capillus202 are indicated to promote hair growth in males with androgenic alopecia who have Norwood Hamilton classifications of IIa to V or females with androgenic alopecia who have Ludwig-Savin Classifications of I – II and both with Fitzpatrick Skin Phototypes I to IV.
For these reasons, the Capillus272 Pro, Capillus272 OfficePro, Capillus82, and Capillus202 satisfy the FDA's substantial equivalence with respect to intended use, technological and design characteristics. With reference to all devices cleared through the OAP device classification, the sponsor respectfully proposes that the FDA has acknowledged that Low-Level Laser/Light Therapy is a viable modality for treating androgenic alopecia in both
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genders and that the red light lasers in class 3R, used in the Capillus devices referenced in this application are substantially equivalent to the predicates. Additionally, no new safety or efficacy concerns are raised due to the minor differences present between devices.
§ 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.