Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical components (LEDs, electronic board) and basic timed operation, with no mention of AI/ML terms, image processing, or data sets for training/testing.

Therapeutic

Yes
The device is indicated to "promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I - II, in males with androgenetic alopecia who have Norwood Hamilton Classifications IIa - V." Promoting hair growth to address alopecia is a therapeutic purpose.

Diagnostic

No
The device is indicated to promote hair growth and describes a treatment using LED lights, not a method for diagnosing a condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "white and grey plastic helmet" housing an "electronic board with all the electrical components and a series of LED diodes," indicating it is a physical hardware device, not software only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to "promote hair growth in females with androgenetic alopecia... and in males with androgenetic alopecia..." This is a therapeutic or cosmetic purpose, not a diagnostic one.
Device Description: The device is a helmet with LEDs that emit light. This is a physical device that interacts with the body externally, not a test performed on biological samples (like blood, urine, or tissue) to diagnose a condition.
Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health status.

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Tricoglam Home Use is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I - II, in males with androgenetic alopecia who have Norwood Hamilton Classifications IIa - V and for both, Fitzpatrick Classification of Skin Phototypes of I - IV.

Product codes

OAP

Device Description

Tricoglam Home Use is a white and grey plastic helmet and inside is housed an electronic board with all the electrical components and a series of LED diodes on a wavelength, protected by a transparent plastic. The energy is distributed homogeneously.
This Helmet is composed by 105 red LEDs arranged uniformly inside the helmet with a wavelength of 650 nm +/- 10 nm.
The program consists of the lighting of all the red diodes for a duration of 20 min in continuous (every day).
To start the treatment the user should press the button on the back and activate the program. All LEDs light up and, after the pre-set 20 minutes, all LEDs turn off.
On the electronic board 105 LED diodes of the latest generation on one side and microelectronic components on the other are housed. The technology used is SMT (as in smartphones, computers, TV) that reduces size, weight and improves efficiency, thus ensuring lower thermal dissipation. On average, each LED produces an optical power of over 5 mW. The viewing angle is greater than 100° and the position of each LED on the electronic board is designed to make the irradiation more homogeneous, calculating the received energy exactly for each cm2 and avoiding the strongly illuminated areas. The total irradiated optical power is greater than 0.63 J. The total continuous energy dose for a 20-minute treatment time is about 1.2 J / cm2.
The power supply has a universal voltage input, so the device can be used anywhere without any intervention.
The home-use system is presented in a closed cardboard box without openings, on the four sides of the box are shown the images and texts of the product for the customer. Overall, the whole package is approximately 31 x 22 x 15 cm with a total weight of 1.20 kg.
The helmet is made of a white and smooth plastic and a colored border, weighs about 0.5 kg avoiding overloading the neck. The dimensions of the product are about 28x19x12 cm. 105 LED diodes equidistant on a flexible electronic board are arranged inside the helmet.
On the upper part of the helmet there are holes that allow the passage of air. During the treatment, the internal temperature undergoes a very modest increase, improving comfort for the user. On the back of the helmet there is the power button and a standard microUSB socket, through which you can power the helmet through any latest generation USB power supply.. Inside there is a rechargeable lithium ion battery that recharges using the same USB port. In this way, treatments can also be performed without connecting the helmet to an external power supply. Considering treatments lasting 20 minutes, the battery is able to ensure at least 2 complete treatments independently. The maximum consumption of the helmet, considering also the recharge of the internal battery, is about 8W to 5V. The optimal operating temperature is between 16 ° C and 37 ° C.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

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)

No clinical trial data for the Tricoglam Home Use was submitted for this 510(k).
Non-clinical performance testing was performed including evaluation to IEC 60601-1-2 to confirm the device's electrical safety and electromagnetic compatibility and conformance with IEC 60601-1-11, IEC 60601-2-57, and IEC 62471.
Material of the helmet are biocompatible according to ISO 10993-5 and ISO 10993-10.
Performance verification and validation testing demonstrates that Tricoglam Home Use meets user needs and design inputs and met requirements for its intended use.
Human factors evaluation of Tricoglam Home Use was considered following IEC 62366-1.
Sufficient data were obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K151516, K161875, K173729, K162071

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

0

Image /page/0/Picture/0 description: The image shows 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.

December 3, 2020

Advihair S.R.L. Angleo D'Andrea Owner Via Benini 11 Zola Predosa, BO 40069 Italy

Re: K193008

Trade/Device Name: Tricoglam Home Use Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: September 25, 2020 Received: October 15, 2020

Dear Angleo D'Andrea:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

1

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K193008

Device Name Tricoglam Home USE

Indications for Use (Describe)

Tricoglam Home Use is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I - II, in males with androgenetic alopecia who have Norwood Hamilton Classifications IIa - V and for both, Fitzpatrick Classification of Skin Phototypes of I - 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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3

510 (k) SUMMARY K193008

SUBMITTER INFORMATION

A. Company Name:	ADVIHAIR S.R.L.
B. Company Address:	Via Benini, 11, Zona industriale – 40069
Zola Predosa (BO)
C. Company Phone:
Company Fax:
Company e-mail:	+39-0517554
angelodandrea@cesareragazzi.it
D. Contact person:	Angleo D'Andrea
Owner
ADVIHAIR s.r.l.
E. Date Summary Prepared:	April 24th, 2019

DEVICE IDENTIFICATION

A. Generic Device Name:	Physical Medicine Therapeutic Devices
B. Trade/Proprietary Name:	TRICOGLAM HOME USE
C. Classification:	Class II
D. Product Code:	OAP
E. Classification Panel:	890 Physical Medicine Therapeutic Devices
F. Regulation Number:	890.5500

LEGALLY MARKETED PREDICATE DEVICE

Predicate device	510 (k) Holder	510 (k) No.	Date cleared
CAPILLUS 82	Capillus LLC	K151516	August 21st, 2015
DermaScalp Laser
Caps (Lasercap80,
Lasercap 120)	Transdermal Cap, Inc.	K161875	June 20th, 2018
Revian Red	PhotonMD, Inc	K173729	February 28th, 2018
Illumiflow Laser
Cap	Eglobal, LLC	K162071	January 23rd, 2017

4

DEVICE DESCRIPTION

Tricoglam Home Use is a white and grey plastic helmet and inside is housed an electronic board with all the electrical components and a series of LED diodes on a wavelength, protected by a transparent plastic. The energy is distributed homogeneously.

This Helmet is composed by 105 red LEDs arranged uniformly inside the helmet with a wavelength of 650 nm +/- 10 nm

The program consists of the lighting of all the red diodes for a duration of 20 min in continuous (every day).

To start the treatment the user should press the button on the back and activate the program. All LEDs light up and, after the pre-set 20 minutes, all LEDs turn off.

Technical data

On the electronic board 105 LED diodes of the latest generation on one side and microelectronic components on the other are housed. The technology used is SMT (as in smartphones, computers, TV) that reduces size, weight and improves efficiency, thus ensuring lower thermal dissipation. On average, each LED produces an optical power of over 5 mW. The viewing angle is greater than 100° and the position of each LED on the electronic board is designed to make the irradiation more homogeneous, calculating the received energy exactly for each cm2 and avoiding the strongly illuminated areas. The total irradiated optical power is greater than 0.63 J. The total continuous energy dose for a 20-minute treatment time is about 1.2 J / cm2.

The power supply has a universal voltage input, so the device can be used anywhere without any intervention.

The home-use system is presented in a closed cardboard box without openings, on the four sides of the box are shown the images and texts of the product for the customer. Overall, the whole package is approximately 31 x 22 x 15 cm with a total weight of 1.20 kg.

The helmet is made of a white and smooth plastic and a colored border, weighs about 0.5 kg avoiding overloading the neck. The dimensions of the product are about 28x19x12 cm. 105 LED diodes equidistant on a flexible electronic board are arranged inside the helmet.

On the upper part of the helmet there are holes that allow the passage of air. During the treatment, the internal temperature undergoes a very modest increase, improving comfort for the user. On the back of the helmet there is the power button and a standard microUSB socket, through which you can power the helmet through any latest generation USB power supply.. Inside there is a rechargeable lithium ion battery that recharges using the same USB port. In this way, treatments can also be performed without connecting the helmet to an external power supply. Considering treatments lasting 20 minutes, the battery is able to ensure at least 2 complete treatments independently.

The maximum consumption of the helmet, considering also the recharge of the internal battery, is about 8W to 5V. The optimal operating temperature is between 16 ° C and 37 ° C.

5

INDICATIONS FOR USE STATEMENT

Tricoglam Home Use is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I - II, in males with androgenetic alopecia who have Norwood Hamilton Classifications IIa - V and for both, Fitzpatrick Classification of Skin Phototypes of I - IV.

SUBSTANTIAL EQUIVALENCE

All information provided with the present submission supports the substantial equivalence for the Tricoglam Home Use with the predicate device and its accessories that have identical characteristics and intended use and similar indication statement. In addition all clinical data and all performance tests that have been performed in accordance with the Standards for the Software Evaluation and for the Electrical and Electromagnetic Safety test, in addition to the requirements for the laser products demonstrate that Tricoglam Home Use devices have safety and effectiveness for its intended use.

The following matrix illustrates the equivalencies of the Tricoglam Home Use, as well as the substantial equivalent predicate devices.

| COMPARISON CHART TRICOGLAM HOME USE | | | | | | | females with
androgenetic
alopecia who
have Ludwig-
Savin
Classification
s I - II, in
males with
androgenetic
alopecia who
have
Norwood
Hamilton
Classification
s IIa - V and
for both,
Fitzpatrick
Classification
of Skin
Phototypes of
I - IV. | have androgenic
alopecia and
Ludwig-Savin
Classifications
of I- II; and with
Fitzpatrick
Classification of
Skin Phototypes
I to IV. | hair growth
in females
with
androgenetic
alopecia who
have
Ludwig-Savin
Classification
s of I- II,
males with
androgenetic
alopecia who
have
amilton-Nor
wood
classification
s IIa-Vand for
both genders,
Fitzpatrick
Classification
of Skin
Phototypes I
to IV | promote hair
growth in
males who
have
Norwood-
Hamilton
Classifications
of IIa - V
patterns of hair
loss and to
treat
Androgenetic
Alopecia and
promote hair
growth in
females who
have Ludwig-
Savin Scale I-1
to I-4, II-1, II-
2 or frontal
patterns of hair
loss; both with
Fitzpatrick
Skin Types I -
IV. | hair growth in
males with
androgenic
alopecia who
have
Norwood-
Hamilton
classification
s of IIa to V
or females
with
androgenic
alopecia who
have
Ludwig-
Savin
Classificatio
ns of I - II
and both
with
Fitzpatrick
Skin
Phototypes I
to IV. |
|--------------------------------------|-------------------------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------------------------|------------------------------------------------------------------------------|----------------------------------------------------------------------|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ADVIHAIR
S.R.L.
TRICOGLAM
HOME USE
New Device | CAPILLUS LLC
Capillus 82
Predicate device | TRANSDER
MAL CAP,
INC.
LaserCap80
LaserCap120
Predicate
device | PHOTO MED,
INC
Revian Red
Predicate device | EGLOBAL,
LLC
Illumiflow
Laser Cap
Predicate
device | Wearable
Mounting | Helmet | Helmet/Cap
Design | Helmet/Cap
Design | Textile Cap | Helmet/Cap
Design |
| "K" NUMBERS | K193008 | K151516 | K161875 | K173729 | K162071 | | | | Lasercap80: 80
Red Laser
Diode
650 nm

Lasercap120:
120 Red Laser
Diode

PREDICATE DEVICES COMPARISON CHART Table 1

Confidential

6

7

Battery	Rechargeable	Rechargeable	Rechargeable	Rechargeable	Rechargeable
	battery	battery	battery	battery	battery
Other Design
Characteristics	after
completion
of time, unit
powers down
Tricoglam
Home
Use
does
not
contain
a
'safety
interlock'
which
automatically
pauses therapy
if the subject's
head is in a
less-than-
optimal
position.	after
completion
of time, unit
powers down	after
completion
of time, unit
powers down	Cap pauses
therapy
if
subject's
head moves
outside zone of
radiation; after
completion of
treatment, unit
powers down,
limits daily
treatment to 10
mins, and
provides
treatment
reminders and
messages via
mobile app
controller	The
Illumiflow
Laser Cap
does not
contain a
'safety
interlock'
which
automatically
pauses
therapy if the
subject's head
is in a less-
than-optimal
position.
The
illumiflow
Laser Cap
does not
utilize audible
tones at the
beginning or
end of
treatment.

TECHNICAL CHARACTERISTICS

A comparison of the technological characteristics of Tricoglam Home Use and the predicate devices has been performed. The results of this comparison demonstrate that the technologic characteristics and the operating principle of the Tricoglam Home Use are the same or very similar to those of the claimed predicate devices. Where any differences arise from the analysis of the predicate device characteristics and those of the device subject of this submission, the clinical data evaluated from scientific publications give scientific evidence of the safety and the effectiveness of the Tricoglam Home Use devices. The system was evaluated and found compliant with IEC 60601-1 for electrical safety, IEC 60601-1-2 for EMI/EMC, and 10993-1 for biocompatibility of the treatment tips. Verification and validation data show that the device meets all product specifications.

PERFORMANCE DATA

No clinical trial data for the Tricoglam Home Use was submitted for this 510(k).

To demonstrate substantial equivalence to the predicate device non clinical performance testing have been performed included evaluation to IEC 60601-1-2 to confirm the device's electrical safety and electromagnetic compatibility and conformance with IEC 60601-1-11, IEC 60601-2-57, and IEC 62471.

Material of the helmet are biocompatible according to ISO 10993-5 and ISO 10993-10. Performance verification and validation testing demonstrates that Tricoglam Home Use meets user needs and design inputs and met requirements for its intended use.

8

Studies Related to Human Factors Evaluation: Human factors evaluation of Tricoglam Home Use was considered following IEC 62366-1.

Sufficient data were obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria.

CLINICAL DATA

The devices have been designed and validated in such a way that, when used under the conditions and for the purposes intended, it will not compromise the clinical condition or the safety of patients, or the safety and health of users or other people, provided that any risk which may be associated with its use constitute acceptable risks when weighed against the benefits to the patient and is compatible with a high level of protection of health and safety.

CONCLUSION

Based on the foregoing, the Tricoglam Home Use is substantially equivalent to the legally marketed, claimed predicate devices for the purposes of this 510 (k) submission. Safety and effectiveness were reasonably assured, justifying 510 (k) clearance.