(57 days)
No
The device description and performance studies focus on LED technology and standard electrical/software testing, with no mention of AI or ML.
Yes
The device is indicated to treat Androgenetic Alopecia and to Promote Hair Growth, which means it is used to alleviate a disease state and improve a physiological function.
No
Explanation: The device is described as an over-the-counter light-emitting diode (LED) device designed to promote hair growth and treat Androgenetic Alopecia, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it includes hardware components: a hair-growing cap, a device base, and a USB power cord. The performance studies also include testing for hardware standards (IEC 60601 series).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for health issues.
- Device Function: The CurrentBody Skin™ Led Hair Regrowth device is a light-emitting device that applies visible red light directly to the scalp. It is a therapeutic device intended to stimulate hair growth, not a diagnostic test performed on a sample.
- Intended Use: The intended use clearly states it is "indicated to treat Androgenetic Alopecia and to Promote Hair Growth." This is a therapeutic indication, not a diagnostic one.
- Device Description: The description details a wearable device that applies light to the scalp, not a system for analyzing biological samples.
Therefore, the CurrentBody Skin™ Led Hair Regrowth device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CurrentBody Skin™ Led Hair Regrowth (MZ-07) is indicated to treat Androgenetic Alopecia and to 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.
Product codes
OAP
Device Description
The CurrentBody Skin™ Led Hair Regrowth, model: MZ-07 is an over-the-counter light-emitting diode (LED) device designed to promote hair growth in women and men by exposing the entire scalp to the photostimulation of visible red light-emitting diodes at 660nm.
The CurrentBody Skin™ Led Hair Regrowth includes a hair-growing cap, a device base and a USB power cord. The user turns on the device and then wears the device on his/her head, and the device will turn off automatically after a 10-minute treatment default.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Visible red light-emitting diodes
Anatomical Site
entire scalp
Indicated Patient Age Range
Not Found
Intended User / Care Setting
OTC
Females & Males
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
The CurrentBody Skin™ Led Hair Regrowth (Model: MZ-07) has been evaluated the safety and performance by lab bench testing as following:
- General requirements for basic safety and essential performance: The test sample is the final, finished product. Test Method/Applicable Standards: IEC 60601-1:2005/(R)2012 & A1:2012,C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]. Acceptance Criteria: The test is carried out under the test method specified in the standard, and the test result is within the test acceptance range of the standard. Results: Pass.
- Electromagnetic disturbances: The test sample is the final, finished product. Test Method/Applicable Standards: IEC 60601-1-2:2020. Acceptance Criteria: No degradation of performance was found during test or Lower than limits of measurement. Results: Pass.
- Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment: The test sample is the final, finished product. Test Method/Applicable Standards: IEC 60601-1-11: 2020. Acceptance Criteria: The device operates normally, and can provide basic safety and essential performance. Results: 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: The test sample is the final, finished product. Test Method/Applicable Standards: IEC 60601-2-57:2011. Acceptance Criteria: The test is carried out under the test method specified in the standard, and the test result is within the test acceptance range of the standard. Results: Pass.
- Photobiological safety of lamps and lamp systems: The test sample is the final, finished product. Test Method/Applicable Standards: IEC 62471:2006. Acceptance Criteria: The test is carried out under the test method specified in the standard, and the test result is within the test acceptance range of the standard. Results: Pass.
Biocompatibility testing:
- Shell (Outer surfaces): Material PC+ABS, Body Contact Category Surface-contacting device: skin, Contact Duration ≤30 mins.
- Shell (Inner surface): Material Silicone, Body Contact Category Surface-contacting device: skin, Contact Duration ≤30 mins.
The Nature of body contact is scalp, skin contact. And the contact duration is less than 24 hours. Applicable biological effects: Cytotoxicity, Irritation or intracutaneous reactivity, Sensitization.
The component materials for Shell (Outer surfaces and inner surface) of the CurrentBody Skin™ Led Hair Regrowth (Models: MZ-07) is identical to the corresponding component for Shell (Outer surfaces and inner surface) of the LED Eye Perfector (Model: EY-36A) in formulation, processing, sterilization, and geometry, and no other chemicals have been added.
Usability Testing: Usability testing was conducted on the CurrentBody Skin™ Led Hair Regrowth (Model: MZ-07), 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, since a malfunction of, or a latent design flaw in, the Software Device leads to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.
Clinical Performance: Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
April 5, 2023
Light Tree Ventures Europe B.V. Alain Dijkstra Manager Laan van Ypenburg 108, 2497 GC Hague. Netherlands
Re: K230336
Trade/Device Name: CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07) Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: January 18, 2023 Received: February 7, 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.
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
1
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 mediation-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).
Sincerelv.
Colin K. Chen -S
for
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) K230336
Device Name
CurrentBody Skin™ Led Hair Regrowth (Model: MZ-07)
Indications for Use (Describe)
The CurrentBody Skin™ Led Hair Regrowth (MZ-07) is indicated to treat Androgenetic Alopecia and to 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.
| 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 for K230336
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: Light Tree Ventures Europe B.V. Address: Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands Contact name: Alain Dijkstra (Manager) Tel: +86-135-10378748 Fax: +86-755-25024651 E-mail: regulation@kaiyanmedical.com
Manufacture
Shenzhen Kaiyan Medical Equipment Co., Ltd Add: Building#3 and Building#5, 40th of Fuxin Street, Huaide Community Fuyong Town, Baoan District, Shenzhen, Guangdong 518103, China
Distributor
Company Name: CurrentBody.com Ltd
Address: Unit D6, Stanley Green Business Park, Commercial Avenue, Cheadle Hulme, Cheshire, SK8 6QH
Application Correspondent:
Contact Person: Alain Dijkstra Light Tree Ventures Europe B.V. Address: Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands Tel: +86-135-10378748 Email: requlation@kaiyanmedical.com
2. Summary Prepared Date
29 March 2023
3. Subject Device Information
Trade Name: CurrentBody Skin™ Led Hair Regrowth
Model: MZ-07
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
4. Predicate Device Information
Sponsor: PhotonMD, Inc. Common Name: Laser, Comb, Hair Classification Name: Infrared Lamp Trade Name: Revian Red 510(K) Number: K173729 Review Panel: General & Plastic Surgery Product Code: OAP Regulation Number: 21 CFR 890.5500 Regulation Class: II
5. Device Description
The CurrentBody Skin™ Led Hair Regrowth, model: MZ-07 is an over-the-counter light-emitting diode (LED) device designed to promote hair growth in women and men by exposing the entire scalp to the photostimulation of visible red light-emitting diodes at 660nm.
The CurrentBody Skin™ Led Hair Regrowth includes a hair-growing cap, a device base and a USB power cord. The user turns on the device and then wears the device on his/her head, and the device will turn off automatically after a 10-minute treatment default.
Intended Use 6.
The CurrentBody Skin™ Led Hair Regrowth (MZ-07) is indicated to treat Androgenetic Alopecia and to Promote Hair Growth in males who have Norwood-Hamilton of Ila - 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.
Comparison to Predicate Device 7.
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 | Verdict |
|---|---|---|---|
| Company | Light Tree Ventures Europe | ||
| B.V. | PhotonMD, Inc. | -- | |
| Trade Name | CurrentBody Skin™ LED Hair | ||
| Regrowth | Revian Red | -- | |
| 510(k) Number | K230336 | K173729 | -- |
| Regulation number | 21 CFR 890.5500 | 21 CFR 890.5500 | Same |
| Classification Name | Infrared Lamp | Infrared Lamp | Same |
| Product Code | OAP | OAP | Same |
| Class | II | II | Same |
| Elements of | |||
| Comparison | Subject Device | Predicate Device | Verdict |
| Intended Use / | |||
| Indications for Use | The LED Hair Regrowth(MZ- |
- is indicated to treat
Androgenetic Alopecia and to
Promote Hair Growth in males
who have Norwood-Hamilton
Classifications of Ila - 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. | The REVIAN RED device is
indicated to treat
Androgenetic Alopecia and to
Promote Hair Growth in males
who have Norwood-Hamilton
Classifications of Ila - 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. | Same |
| Location for use | OTC | OTC | Same |
| Intended User | Females & Males | Females & Males | Same |
| Type of light | Visible red light-emitting
diodes | Visible red light-emitting
diodes | Same |
| Wavelength | 660 nm | 620-660 nm | Similar
Note1 |
| Amount of diodes | 120 | 119 | Similar
Note 2 |
| Power Supply | lithium battery | lithium polymer | Same |
| Irradiance | 1.67 mw/cm² | Not available | Different
Note 3 |
| Fluence | 1 J/cm² | Not available | Different
Note 3 |
| Distribution | Uniform distribution | Uniform distribution | Same |
| Treatment Time | Every day 10 mins | Every day 10 mins | Same |
| Helmet/Cap design | Yes | Yes | Same |
| Safety | Complied with IEC 60601-1,
IEC 60601-1-2, IEC 60601-1-
11, IEC 60601-2-57, IEC
62471, IEC 62133-2 | Complied with IEC 60601-1,
IEC 60601-1-2, IEC 60601-1-
11, IEC 62471 | Same |
| Biocompatibility | All patient contacting materials
are complied with ISO 10993-
5, ISO 10993-10 | All patient contacting
materials are comply with ISO
10993-5, ISO 10993-10 | Same |
5
Comparison in Detail(s):
Note 1:
Although the "Wavelength" of the subject device is slightly different from the predicate device, the wavelength of the subject device is included in the wavelength range of the predicate device. So, the difference between the subject device and the predicate device will not raise any safety or effectiveness issues.
6
Note 2:
Although the "Amount of diodes" of the subject device is slightly different from the predicate device, specifications between them is different and the overall fluence is similar. So, the slightly difference between the subject device and the predicate device will not raise any safety or effectiveness issues.
Note 3:
Although there is no publicly available of the "irradiance" and the "fluence" for the predicate device, the subject device has the same / similar treatment parameters in "wavelength", "amount of diodes", "distribution" and "treatment time" with the predicate device. So, the difference between the subject device and the predicate device will not raise any safety or effectiveness issues.
8. Test Summary
7.1 Summary of Non-Clinical Performance Testing
Performance Testing Summary 1)
The CurrentBody Skin™ Led Hair Regrowth (Model: MZ-07) has been evaluated the safety and performance by lab bench testing as following:
| Title of the test | Device
Description/Sample
Size | Test
Method/Applicable
Standards | Acceptance
criteria | Unexpected
Results/
Significant
Deviations | Test
results |
|-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|-----------------|
| General
requirements
for basic safety
and essential
performance | The test
sample is
the final,
finished
product. | 2005/(R)20
12 &
A1:2012,
C1:2009/(R
)2012 &
A2:2010/(R)
2012
(Cons.
Text) [Incl.
AMD2:2021
] | The test is
carried out
under the test
method
specified in the
standard, and
the test result
is within the
test
acceptance
range of the
standard. | NA | Pass |
| Electromagnetic
c disturbances | The test
sample is
the final,
finished
product. | IEC 60601-
1-2:2020 | No degradation
of performance
was found
during test or
Lower than
limits of
measurement. | NA | Pass |
| Requirements
for medical
electrical
equipment and
medical
electrical
systems used | The test
sample is
the final,
finished
product. | IEC 60601-
1-11: 2020 | The device
operates
normally, and
can provide
basic safety
and essential
performance | NA | Pass |
7
| in the home
healthcare
| environment | |||||
|---|---|---|---|---|---|
| Particular | |||||
| Requirements | |||||
| for The Basic | |||||
| Safety And | |||||
| Essential | |||||
| Performance Of | |||||
| Non-Laser Light | |||||
| Source | |||||
| Equipment | |||||
| Intended For | |||||
| Therapeutic, | |||||
| Diagnostic, | |||||
| Monitoring And | |||||
| Cosmetic/Aesth | |||||
| etic Use | The test | ||||
| sample is | |||||
| the final, | |||||
| finished | |||||
| product. | IEC 60601- | ||||
| 2-57:2011 | The test is | ||||
| carried out | |||||
| under the test | |||||
| method | |||||
| specified in the | |||||
| standard, and | |||||
| the test result | |||||
| is within the | |||||
| test | |||||
| acceptance | |||||
| range of the | |||||
| standard. | NA | Pass | |||
| Photobiological | |||||
| safety of lamps | |||||
| and lamp | |||||
| systems. | The test | ||||
| sample is | |||||
| the final, | |||||
| finished | |||||
| product. | IEC | ||||
| 62471:2006 | The test is | ||||
| carried out | |||||
| under the test | |||||
| method | |||||
| specified in the | |||||
| standard, and | |||||
| the test result | |||||
| is within the | |||||
| test | |||||
| acceptance | |||||
| range of the | |||||
| standard. | NA | Pass |
2)
The patient directly contracting materials in the subject device are showed in the following list.
| Components of
Subject Device | Material of
Components | Body Contact
Category
(ISO 10993-1) | Contact Duration
(ISO 10993-1) |
|---------------------------------|---------------------------|-------------------------------------------|-----------------------------------|
| Shell (Outer surfaces) | PC+ABS | Surface-contacting
device: skin | ≤30 mins |
| Shell (Inner surface) | Silicone | Surface-contacting
device: skin | ≤30 mins |
The Nature of body contact is scalp, skin contact. And the contact duration is less than 24 hours. According to Table 1 - Initial evaluation tests for consideration in ISO 10993-1, the applicable biological effect is:
- Cytotoxicity
- Irritation or intracutaneous reactivity .
- . Sensitization
8
The component materials for Shell (Outer surfaces and inner surface) of the CurrentBody Skin™ Led Hair Regrowth (Models: MZ-07) is identical to the corresponding component for Shell (Outer surfaces and inner surface ) of the LED Eye Perfector (Model: EY-36A) in formulation, processing, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents), that manufactured by Light Tree Ventures Europe B.V. and has been cleared in K221444 on December 08, 2022.
3) Usability Testing
Usability testing was conducted on the CurrentBody Skin™ Led Hair Regrowth (Model: MZ-07), the device complies with IEC 62366-1 and IEC 60601-1-6.
4) 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, since a malfunction of, or a latent design flaw in, the Software Device leads to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.
5) Cybersecurity
The subject device no any external interfaces, according to FDA guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", no need cybersecurity evaluation.
7.2 Clinical Performance
Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively.
9. Conclusion
The subject device is as safe, as effective, and performs as well as or better than the legally marketed predicated devices K173729.