(84 days)
Not Found
No
The device description and performance studies focus on the hardware (LEDs and lasers) and basic operational modes (continuous/pulse, fixed treatment time). There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
Yes.
The device is indicated to promote hair growth in individuals with androgenetic alopecia, which is a medical condition, making it a therapeutic device.
No
The device is indicated to "promote hair growth" and offers treatment modalities, not to diagnose a condition.
No
The device description clearly states it is a "combination of 650±5nm low-level laser diodes and 650±5nm light emitting diodes" and mentions "laser diodes (LDs) and light-emitting diodes (LEDs)" as physical components. This indicates it is a hardware device that utilizes light therapy, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The NOOANCE LED AND LASER HELMET is a device that applies light energy directly to the scalp to stimulate hair growth. It does not involve testing any samples taken from the body.
- Intended Use: The intended use is to promote hair growth, not to diagnose, monitor, or screen for any medical condition through in vitro testing.
- Device Description: The description focuses on the physical components (LEDs, lasers) and how they are used externally on the head.
- Performance Studies: The performance studies mentioned are related to electrical safety, usability, and software validation, not the accuracy or performance of in vitro tests.
Therefore, the NOOANCE LED AND LASER HELMET falls under the category of a therapeutic or cosmetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NOOANCE LED AND LASER HELMET is indicated to promote hair growth in males with androgenetic alopecia who have HamiltonNorwood Classifications of Ila-V and Fitzpatrick Classification of Skin Phototypes I to IV, and females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV.
Product codes (comma separated list FDA assigned to the subject device)
OAP
Device Description
The NOOANCE LED AND LASER HELMET is an over-the-counter device designed to promote hair growth in person with androgenetic alopecia in women and men. The device is a combination of 650±5nm low-level laser diodes and 650±5nm light emitting diodes. Red light of specific spectrum combined with low-lever laser directly irradiated into hair follicles has been shown to help promote hair growth. It has two models, M-120 and M-282 PRO. The difference between them is the number of laser diodes (LDs) and light-emitting diodes (LEDs). The model M-120 is a combination of 51 class 1C low-level LDs and 69 LEDs. And the model M-282 PRO has 82 class 1C low-level LDs and 200 LEDs.
The device has two working modes. Mode 1 is continuous which has no frequency setting. Mode 2 is pulse with a frequency. User long presses the ON/OFF button to turn on the device and tap the ON/OFF button to select the preferred mode. Then press the start/pause button to start the treatment, treatment time is fixed for 25 minutes. The device is designed to automatically pause therapy if it is removed from the head and resume therapy when positioned on the head within 5 minutes and the start/pause button is pressed. Once the treatment complete, the device will turn off automatically with two "beep" sounds.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hair follicles / head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter 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)
Non-Clinical Performance Testing Summary:
- General requirements for basic safety and essential performance (IEC 60601-1: Edition 3.2 2020-08). Test result: Pass.
- Electromagnetic disturbances (IEC 60601-1-2: Edition 4.1 2020-09). Test result: Pass.
- Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11: Edition 2.1 2020-07). Test result: Pass.
- Particular Requirements for The Basic Safety And Essential Performance Of Non-Laser Light Source Equipment Intended For Therapeutic, Diagnostic, Monitoring And Cosmetic/Aesthetic Use (IEC 60601-2-57: Edition 1.0 2011-01). Test result: Pass.
- Photobiological safety of lamps and lamp systems (IEC 62471: First edition 2006-07). Test result: Pass.
- Safety of laser products - Part 1: Equipment classification, and requirements (IEC 60825-1: Edition 2.0 2007-03). Test result: Pass.
Biocompatibility: The component materials for Outer Shell of the helmet and the controller are identical to the corresponding component for Shell of the CurrentBody Skin™ Led Hair Regrowth (Model: MZ-07) cleared in K230336.
Usability Testing: Usability testing was conducted on the NOOANCE LED AND LASER HELMET (Model: M-120, M-282 PRO), the device complies with IEC 62366-1 and IEC 60601-1-6.
Software Verification and Validation Testing: Software verification and validation testing were conducted and documentation was provided as recommended by FDA'S Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level concern.
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 contains 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.
July 31, 2023
Shenzhen Kaiyan Medical Equipment Co., Ltd Alain Dijkstra CEO Building#3 and Building#5, 40th of Fuxin Street Huaide Community, Fuyong Town, Baoan District Shenzhen, Guangdong 518103 China
Re: K231321
Trade/Device Name: Nooance Led And Laser Helmet Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: May 6, 2023 Received: May 8, 2023
Dear Alain Dijkstra:
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 (QS) 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.
Jianting Wang -S
Jianting Wang Acting 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) K231321
Device Name NOOĀNCE LED AND LASER HELMET (Model: M-120, M-282 PRO)
Indications for Use (Describe)
The NOOANCE LED AND LASER HELMET is indicated to promote hair growth in males with androgenetic alopecia who have HamiltonNorwood Classifications of Ila-V and Fitzpatrick Classification of Skin Phototypes I to IV, and females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 801 CFR Subpart D) |
|---|
| Over-The-Counter Use (801 CFR 801 Subpart C) |
|_ | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary of K231321
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
1. Submitter Information
Sponsor Name: Shenzhen Kaiyan Medical Equipment Co., Ltd Address: Building#3 and Building#5, 40th of Fuxin Street, Huaide Community Fuyong Town, Baoan District, Shenzhen, Guangdong 518103, China Contact name: Alain Dijkstra (CEO) Tel: 0755-82129361 Fax: 0755-25024651 E-mail: regulation@kaiyanmedical.com
Distributor
Company Name: NOOANCE INNOVATIONS Address: 22 Rue Beaujon, 75008 Paris, France
Application Correspondent:
Contact Person: Mr. Alain Dijkstra Shenzhen Kaiyan Medical Equipment Co., Ltd Address: Building#3 and Building#5, 40th of Fuxin Street, Huaide Community Fuyong Town, Baoan District, Shenzhen, Guangdong 518103, China Tel: +86 755 82129361 Fax: +86 755 25024651 Email: regulation@kaiyanmedical.com
2. Summary Prepared Date
6 May, 2023
Subject Device Information 3.
Trade Name: NOOÃNCE LED AND LASER HELMET Model: M-120, M-282 PRO Common Name: Laser, Comb, Hair Classification Name: Infrared Lamp Review Panel: General & Plastic Surgery Product Code: OAP Regulation Number: 21 CFR 890.5500 Regulation Class: II
4. Predicate Device Information Predicate Device 1
Sponsor: Raymond R. Blanche Common Name: Laser, Comb, Hair Classification Name: Infrared Lamp Trade Name: iRestore Professional 282
4
510(K) Number: K183417 Review Panel: General & Plastic Surgery Product Code: OAP Regulation Number: 21 CFR 890.5500 Regulation Class: II
Predicate Device 2
Sponsor: Chongqing Peninsula Medical Technology Co., Ltd. Trade Name: Irradiation Cosmetic Device Model: HairPro Plus 510(k) Number: K192552 Common Name: Laser, Comb, Hair Classification Name: Infrared lamp Review Panel: General & Plastic Surgery Product Code: OAP Regulation Number: 21 CFR 890.5500 Regulation Class: Class II
Predicate Device 3
Sponsor: Light Tree Ventures Europe B.V. Trade Name: CurrentBody Skin™ LED Hair Regrowth Model: MZ-07 510(k) Number: K230336 Common Name: Laser, Comb, Hair Classification Name: Infrared lamp Review Panel: General & Plastic Surgery Product Code: OAP Regulation Number: 21 CFR 890.5500 Regulation Class: Class II
5. Device Description
The NOOANCE LED AND LASER HELMET is an over-the-counter device designed to promote hair growth in person with androgenetic alopecia in women and men. The device is a combination of 650±5nm low-level laser diodes and 650±5nm light emitting diodes. Red light of specific spectrum combined with low-lever laser directly irradiated into hair follicles has been shown to help promote hair growth. It has two models, M-120 and M-282 PRO. The difference between them is the number of laser diodes (LDs) and light-emitting diodes (LEDs). The model M-120 is a combination of 51 class 1C low-level LDs and 69 LEDs. And the model M-282 PRO has 82 class 1C low-level LDs and 200 LEDs.
The device has two working modes. Mode 1 is continuous which has no frequency setting. Mode 2 is pulse with a frequency. User long presses the ON/OFF button to turn on the device and tap the ON/OFF button to select the preferred mode. Then press the start/pause button to start the treatment, treatment time is fixed for 25 minutes. The device is designed to automatically pause therapy if it is removed from the head and resume therapy when positioned on the head within 5 minutes and the start/pause button is pressed. Once the treatment complete, the device will turn off automatically with two "beep" sounds.
5
6. Indications for Use
The NOOÃNCE LED AND LASER HELMET is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of Ila-V and Fitzpatrick Classification of Skin Phototypes I to IV, and females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV.
7. Comparison to Predicate Devices
Compare with predicate device, the subject device is very similar in design principle, intended use, indications for use, functions and the applicable standards. The differences between subject device and predicate device do not raise and new questions of safety or effectiveness.
| Elements of
Comparison | Subject Device | Predicate
Device 1 | Predicate
Device 2 | Predicate
Device 3 | Verdict |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Company | Shenzhen Kaiyan
Medical Equipment
Co., Ltd | Raymond
R.
Blanche | Chongqing
Peninsula
Medical
Technology
Co., Ltd. | Light
Ventures
Europe
B.V. | -- |
| Trade Name | NOOĀNCE LED AND
LASER HELMET | iRestore
Professional
282 | Irradiation
Cosmetic
Device | CurrentBody
Skin™
LED
Hair
Regrowth | -- |
| Model | M-120, M-282 PRO | / | HairPro Plus | MZ-07 | / |
| 510(k)
Number | K231321 | K183417 | K192552 | K230336 | -- |
| Common
name | Laser, Comb, Hair | Laser,
Comb,
Hair | Laser,
Comb,
Hair | Laser,
Comb,
Hair | Same |
| Classification
Name | Infrared Lamp | Infrared Lamp | Infrared lamp | Infrared lamp | Same |
| Review panel | General & Plastic
Surgery | General
&
Plastic Surgery | General
&
Plastic Surgery | General
&
Plastic Surgery | Same |
| Product
Code | OAP | OAP | OAP | OAP | Same |
| Regulation
number | 21 CFR 890.5500 | 21
CFR
890.5500 | 21 CFR
890.5500 | 21
CFR
890.5500 | Same |
| Regulation
Class | Class II | Class II | Class II | Class II | Same |
| Intended Use
/ Indications
for Use | The NOOĀNCE LED
AND LASER
HELMET is indicated
to promote hair
growth in males with
androgenetic
alopecia who have
Hamilton-Norwood
Classifications of IIa-
V and Fitzpatrick
Classification of Skin
Phototypes I to IV | The iRestore
Professional
282
is
indicated
to
promote
hair
growth
in
females
with
androgenetic
alopecia
who
have
Ludwig-Savin
Classifications | The Irradiation
Cosmetic
Device is
indicated
to
promote
hair
growth
in
females
with
androgenetic
alopecia
who
have Ludwig-
Savin
Classifications | The
CurrentBody
Skin™
Led
Hair Regrowth
(MZ-07) is
indicated
to
treat
Androgenetic
Alopecia
and
to
Promote
Hair
Growth
in | Same |
| Elements of
Comparison | Subject Device | Predicate
Device 1 | Predicate
Device 2 | Predicate
Device 3 | Verdict |
| | and females with
androgenetic
alopecia who have
Ludwig-Savin
Classifications of I-II
and Fitzpatrick
Classification of Skin
Phototypes I to IV. | of I-II, males
who have
Norwood-
Hamilton
Classifications
of IIa-V and for
both,
Fitzpatrick
Classification
of Skin
Phototypes I to
IV. | of I - II and
males with
androgenetic
alopecia who
have Norwood-
Hamilton
Classifications
of IIa - V and
for both,
Fitzpatrick
Classification
of Skin
Phototypes I to
IV | 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. | |
| Type for use | OTC | OTC | OTC | OTC | Same |
| Intended
User | Females & Males | Females &
Males | Females &
Males | Females &
Males | Same |
| Type of light | Low-level laser
diodes and light
emitting diodes | Low-level laser
diodes and
light emitting
diodes | Visible red
laser | Visible red
light-emitting
diodes | Same as
K183417 |
| Wavelength | Laser: 650±5 nm
Red light LED: 650±5
nm | 650 ±10 nm | 650±5 nm | 660 nm | Same |
| Number of
diodes | M-120:
LDs: 51
LEDs: 69
M-282 PRO:
LDs: 82
LEDs: 200 | LDs: 82
LEDs: 200 | 272 | 120 | Similar
Note 1 |
| Irradiance | M-120: approximately
1.3 mw/cm²
M-282 PRO:
approximately 2.8
mw/cm² | Not available | 2.7454
mw/cm² | 1.67 mw/cm² | Similar
Note 2 |
| Fluence | M-120: approximately | Not available | 4.9417 J/cm2 | 1 J/cm² | Similar |
| Elements of
Comparison | Subject Device | Predicate
Device 1 | Predicate
Device 2 | Predicate
Device 3 | Verdict |
| | 1.9 J/cm²
M-282 PRO:
approximately 4.2
J/cm² | | | | Note 2 |
| Distribution | Uniform distribution | Uniform
distribution | Uniform
distribution | Uniform
distribution | Same |
| Laser
classification
according to
IEC 60825-1 | Class 1C | Class 3R | Class 3R | Not available | Different
Note 3 |
| Power output |