(39 days)
Not Found
No
The device description and performance studies focus on low-level laser therapy and electrical safety standards, with no mention of AI or ML technologies.
Yes
The device is indicated to "promote hair growth" for androgenic alopecia, which is a medical condition. Therefore, it is intended to affect the structure/function of the body, classifying it as a therapeutic device.
No
This device is used to promote hair growth, which is a therapeutic function, not a diagnostic one. It delivers non-thermal energy to hair follicles rather than detecting or identifying a condition.
No
The device description explicitly states it is a "low-level laser therapy (LLLT) helmet device containing red. visible light diode lasers" and mentions testing to hardware standards like IEC 60601-1 and IEC 60825-1, indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The illumiflow 148 Laser Cap is a low-level laser therapy (LLLT) device that applies light energy directly to the scalp. It does not analyze any biological samples taken from the body.
- Intended Use: The intended use is to promote hair growth by stimulating hair follicles on the scalp, not to diagnose or monitor a condition based on in vitro analysis.
The information provided clearly describes a device that interacts with the body externally to achieve a therapeutic effect, which is not the function of an IVD.
N/A
Intended Use / Indications for Use
The illumiflow 148 Laser Cap is 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 Hair Classifications of I-II and both with Fitzpatrick Skin Phototypes I to IV
Product codes (comma separated list FDA assigned to the subject device)
OAP
Device Description
Similar to the original illumiflow 272 Laser Cap and the predicate LaserCap 120, the modified illumiflow 148 Laser Cap is a low-level laser therapy (LLLT) helmet device containing red. visible light diode lasers operating at 650 nanometers, designed to deliver non-thermal energy to the hair follicles used to promote hair growth via photobiostimulation of the scalp.
The illumiflow 148 Laser Cap utilizes 148 laser diodes to deliver laser stimulation to the scalp. The device is operated via a single button on the battery pack, and has an audible timer that automatically turns the lasers off after a 30-minute treatment session.
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
Home
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)
Nonclinical performance data includes:
- Testing to IEC 60601-1 and 60601-1-2 confirming the device's safety and electrical compatibility.
- Testing to IEC 60825-1 certifying the laser system to classification 3R, the same as the predicate device.
- The charger conforms to IEC-60950.
- Testing to 60601-1-11 confirming the safety of the device for use in a home use environment.
- The Battery Pack conforms to IEC 62133.
- EGlobal, LLC performed a Risk Analysis to evaluate the implications of the design changes to the illumiflow 272 Laser Cap. It was determined there was no significant change to risk and no new risks were identified. All residual risks were found to be acceptable.
- Verification activities were conducted for the illumiflow 148 Laser Cap, including the same methods and tests using the same applied acceptance criteria as the previous illumiflow 272 Laser Cap. All of the testing met acceptance criteria.
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.
Not Found
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
§ 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/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in a stacked format. The overall design is clean and professional, reflecting the organization's role in public health and safety.
January 26, 2018
EGlobal, LLC % Ms. Liza Burns Liza Burns and Associates 6469 G Kawaihau Road Kapaa, Hawaii 96746
Re: K173843
Trade/Device Name: illumiflow 148 Laser Cap Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: December 8, 2017 Received: December 18, 2017
Dear Ms. Burns:
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 manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
Page 2 - Ms. Liza Burns
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 medical devices and radiation-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 -S3
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) K173843
Device Name illumiflow 148 Laser Cap
Indications for Use (Describe)
The illumiflow 148 Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of Ila to V or females with androgenic alopecia who have Ludwig-Savin Hair Classifications of I-II and both with Fitzpatrick Skin Phototypes I to IV
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K173843
illumiflow 148 Laser Cap: Special 510(k) Summary
- Sponsor: EGlobal, LLC 10115 E Bell Road, Suite 107 Scottsdale, AZ 85260 Phone: 877-364-5242 Fax: 808-443-0123 Email: w@premiumweb.com
- Contact: Liza Burns, Regulatory Consultant Liza Burns and Associates 6469G Kawaihau Road Kapaa, Hawaii 96746 Phone: 808-823-8068 Fax: 808-443-0123 Email: lizaburns@mlode.com
| Date Summary Prepared: | January 26, 2018 |
|---|---|
| Device Trade Name: | illumiflow 148 Laser Cap |
| Common Name: | Laser Helmet |
| Classification Name: | Laser, Comb, Hair (Infrared lamp) |
| Product Code: | OAP |
| Classification of Device: | Class II (performance standards) |
| Classification Regulation: | Title 21, Code of Federal Regulations, §Sec.890.5500. 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. |
| Predicate Devices: | illumiflow 272 Laser Cap, model CSM-010 (K162071) |
| LaserCap 120 (K161875) | |
| Performance Standards: | FDA mandated performance standards for this device exist and are specified under 21 CFR, §1010 and §1040. These standards, including QSR requirements are followed by regulation. Voluntary standards such as UL, in-house Standard Operating |
4
Procedures and vendor qualification procedures are in place and utilized in the production of the illumiflow 148 Laser Cap. At the present time, the following applicable guidance documents are in effect for this device:
- Guidance on the Content and Organization of a Premarket ● Notification for a Medical Laser (June 1995)
- Compliance Guide for Laser Products (FDA 86-8260) ●
- . Laser Products. Conformance with IEC 60825-1. and IEC 60601-2-22; Guidance for Industry and FDA (Laser Notice 50)
Device Description:
Similar to the original illumiflow 272 Laser Cap and the predicate LaserCap 120, the modified illumiflow 148 Laser Cap is a low-level laser therapy (LLLT) helmet device containing red. visible light diode lasers operating at 650 nanometers, designed to deliver non-thermal energy to the hair follicles used to promote hair growth via photobiostimulation of the scalp.
The illumiflow 148 Laser Cap utilizes 148 laser diodes to deliver laser stimulation to the scalp. The device is operated via a single button on the battery pack, and has an audible timer that automatically turns the lasers off after a 30-minute treatment session.
Intended Use/Indication for Use:
The illumiflow 148 Laser Cap is an over-the-counter (OTC) device intended 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 Hair Classifications of I-II and both with Fitzpatrick Skin Phototypes I to IV.
Technological Characteristics:
The modifications to the illumiflow 272 Laser Cap since its previous clearance in K162071 have resulted in the illumiflow 148 Laser Cap (Model CSM-020) and do not alter the safety or efficacy of the device. The parent/predicate device contains 272 laser diodes. The modified illumiflow 148 Laser Cap utilizes the same individual laser diodes and helmet design. The difference in the illumitlow 148 Laser Cap when compared to the illumiflow 272 Laser Cap is the number of laser diodes: the illumiflow 148 Laser Cap contains 148 diodes and the illumiflow 272 Laser Cap contains 272 laser diodes. Due to the reduced number of diodes, the 15-minute treatment option of the parent illumiflow 272 Laser Cap (which instructed the user to treat for either a 15 or 30-minute duration) has been eliminated, and the illumiflow 148 Laser Cap will only utilize a 30-minute treatment duration. Even though the dosage per treatment is reduced, over time the delivered dosage remains similar to the parent illumiflow 272 Laser Cap, as both caps are intended to be used indefinitely. The modified device is an economical version of the current illumiflow 272 Laser Cap.
Nonclinical Performance Data:
5
Performance Characteristics
Testing to IEC 60601-1 and 60601-1-2 confirm the device's safety and electrical compatibility.
Testing to IEC 60825-1 certifies the laser system to classification 3R, the same as the predicate device.
The charger conforms to IEC-60950.
Testing to 60601-1-11 confirms the safety of the device for use in a home use environment.
The Battery Pack conforms to IEC 62133.
Nonclinical Testing
EGlobal, LLC performed a Risk Analysis to evaluate the implications of the design changes to the illumiflow 272 Laser Cap. It was determined there was no significant change to risk and no new risks were identified with respect to the modifications which constitute the illumiflow 148 Laser Cap. All residual risks were found to be acceptable. It was concluded that the modified design could be tested in the laboratory and that no animal or new clinical data was required to show safety, efficacy or substantial equivalence to the currently cleared model.
Based on the Risk Analysis and modifications to the device, verification activities were conducted for the illumiflow 148 Laser Cap, including the same methods and tests using the same applied acceptance criteria as the previous illumiflow 272 Laser Cap. All of the testing met acceptance criteria.
Substantial Equivalence:
The illumiflow 148 Laser Cap claims substantial equivalence to the illumiflow 272 Laser Cap CSM-010 (K162071), and the LaserCap 120 (K161875); these devices are equivalent to the illumiflow 148 Laser Cap in technological characteristics as well as in the number of weekly treatments and in the case of the LaserCap 120, the reduced number of diodes. The Feature Comparison Table (below), demonstrates the similarities and minor differences between the subject device and its parent/predicate devices to determine substantial equivalence. Differences between the subject device and the predicate devices are highlighted in yellow.
Feature Comparison Table
| Feature | Subject: illumiflow 148 | Parent Model: illumiflow
272 (K162071) | Predicate: LaserCap 120
(K161875) |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| OTC/Rx | OTC | OTC | Rx |
| Home/Clinic | Home | Home | Home |
| Treatment
Time | 30 minutes | 15 – 30 minutes | 36 minutes |
| Treatment
Schedule | Every other day (3-4
times per week) | Every other day (3-4 times per week) | Every other day (3-4 times per week) |
| Power Source | Li-Ion Battery
AC Charger | Li-Ion Battery
AC Charger | Li-Ion Battery
AC Charger |
| Form Factor | Helmet | Helmet | Helmet |
| Instructions
for Use | Place on head.
Press power button on
battery pack. Leave on
until audible timer
completes (at 30
minutes). Patient
operated. | Place on head
Press power button on
battery pack. Leave on until
audible timer completes
(indicating 30 minutes) or
until 15 minutes have
elapsed. Patient operated. | Place on head
Turn Power Pack switch 'on.
When device emits an audible tone,
indicating that therapy ended (one long
beep).
turn Power Pack switch 'off.'
Patient operated |
| User
Features/Input | One Button Operation
Audible Timer
Status LED | One Button Operation
Audible Timer
Status LED | One Button Operation
Audible Timer
Status LED: unknown |
| Intended use | intended 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 Hair
Classifications of I-II and
both with Fitzpatrick Skin
Phototypes I to IV. | Same | Same |
| Output power
(per diode) | ' Mathematically calculated: There are 120 diodes in the LaserCap, operating at approximately 5mW per diode, making the power output calculation 120 diodes x 5mW = 600mW.
2 Mathematically calculated: Verification test results in Section 14 of this 510k submission provide the following:
Laser Array Test: measure diode output: 5mW +/-10% [PASS]
Laser Cap Functional Test: laser power within the cap: 5mW +/-10% [PASS]
There are 148 diodes in the Laser Cap, operating at approximately 5mW per diode, making the power output calculation 148 diodes x 5mW = 740mW.
9
EGlobal, LLC asserts that the illumiflow 148 Laser Cap with its 148 diodes and 30-minute treatment session time is equivalent in form, function, safety, and efficacy to the current illumiflow 272 Laser Cap and the LaserCap 120; in addition, the LaserCap 120 predicate provides evidence of an FDA cleared device in the OAP product code with an energy dose similar in performance to the illumiflow 148 Laser Cap, both of which utilize fewer laser diodes than their predicates for the same intended use.