(69 days)
Not Found
No
The device description focuses on hardware components (lasers, LEDs, sensors) and basic automated functions (pausing/resuming therapy based on position, automatic shut-off). There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies. The performance studies listed are related to safety and basic device performance, not AI/ML model validation.
Yes
The device is intended to promote hair growth in individuals with androgenetic alopecia, which is a medical condition, indicating a therapeutic purpose.
No
The device is intended to promote hair growth and is not used for diagnosis or detection.
No
The device description explicitly states it consists of physical components like laser diodes, LEDs, an outer helmet, and an inner liner, and is powered by a battery or external adapter. This indicates it is a hardware device, not software-only.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The easy Hairfull is a light therapy device that applies red laser and LED light directly to the scalp to promote hair growth. It does not analyze any biological samples.
- Intended Use: The intended use is to promote hair growth in individuals with androgenetic alopecia, which is a therapeutic application, not a diagnostic one.
The device description and intended use clearly indicate that it is a therapeutic device for external use, not a diagnostic device that analyzes samples.
N/A
Intended Use / Indications for Use
The easy Hairfull is intended to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Classification of Skin Phototypes I to IV, and in 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 easy Hairfull is basically an identical device with the 510(k)-cleared device Hair up (K180617). A new 510(k) clearance is applied this time with the difference in the location of the controller and battery. The controller where the battery embedded is located on the headset at this time.
The easy Hairfull consists of 21 red visible laser diodes (LDs) and 30 red light emitting diodes (LEDs) configured within an outer helmet and protective inner liner. The use of LDs and LEDs provides for a full coverage of the upper 1/3 of the head where commonly covered with stylized hair. The system automatically pauses therapy when the device is not in the correct head position and resumes treatment when the correct head position is re-established. At the end of the therapy cycle, the system signals that therapy is complete and the device will automatically turn off.
The device could be powered by internal rechargeable li-on battery, and it can also be supplied by specified external adapter with Input AC 100-240V, 50/60Hz and Output DC 5V, 2A.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper 1/3 of the 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 tests: Measurement of wavelength and average output power, of treatment were performed. Testing conducted on the easy Hairfull shows that it refers to the relevant mandatory performance standards for laser products 21 CFR 1040.10 and 1040.11. Other performance, such as basic safety, etc, were tested using following consensus standards:
- Basic safety and essential performance of the easy Hairfull is tested and evaluated according to IEC 60601-1:2005.
- Effect to the device by electromagnetic disturbances were tested and evaluated according to the FDA-recognized consensus standard. IEC 60601-1-2:2014.
- -Safety of laser products is evaluated according to FDA-recognized consensus standard, IEC 60825-1: 2014.
- Photobiological safety of lamps and lamp systems is evaluated according to FDA-recognized consensus standard, IEC 62471:2006.
- -Risk management was recorded by referring to ISO 14971:2007.
- -Usability was documented referring to IEC 60601-1-6.
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 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 in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
December 8, 2020
Y&J BIO Co., Ltd. % Paweena U-Thainual CEO MDR Solutions Co., Ltd 1435 Kanjanapisek Road, Bang Khae Nuea Bangkok, Bang Khae 10160 Thailand
Re: K202983
Trade/Device Name: easy Hairfull Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: September 28, 2020 Received: September 30, 2020
Dear Paweena U-Thainual:
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 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) K202983
Device Name easy Hairfull
Indications for Use (Describe)
The easy Hairfull is intended to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Classification of Skin Phototypes I to IV, and in 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 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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5. 510(k) Summary
1. General Information
| Applicant/Submitter: | Y&J BIO Co., Ltd. |
|---|---|
| Address: | B-916 ,947, Hanam-daero, Hanam-si, |
| Gyeonggi-do, Republic of Korea | |
| Tel) +82-31-5180-3491 | |
| Contact Person: | Paweena U-Thainual, MDR Solutions Co., Ltd. |
| Address: | 1435 Kanjanapisek Road, Bang Khae Nuea, |
| Bang Khae, Bangkok, THAILAND 10160 | |
| Tel: +66-2-804-2101 | |
| Email: paweena@mdrsolutions.co.th | |
| Preparation Date: | September 18, 2020 |
2. Device Name and Code
| Device Trade Name: | easy Hairfull |
|---|---|
| Common Name: | Lamp, non-heating, for promotion of hair growth |
| Classification Name: | Infared lamp |
| Product Code: | OAP |
| Regulation Number: | 890.5500 |
| Classification: | Class II |
| Review Panel: | General & Plastic Surgery |
3. Predicate Devices
Easy Hairfull is substantially equivalent to the following device
| Table 5.1 Predicate devices | |
|---|---|
| -- | ----------------------------- |
| Applicant | Device Name | 510(k) Number |
|---|---|---|
| Y&J BIO Co., Ltd. | Hair Up | K180617 |
4. Device Description
The easy Hairfull is basically an identical device with the 510(k)-cleared device Hair up (K180617). A new 510(k) clearance is applied this time with the difference in the location of the
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easy Hairfull
510(k) Summary
controller and battery. The controller where the battery embedded is located on the headset at this time.
The easy Hairfull consists of 21 red visible laser diodes (LDs) and 30 red light emitting diodes (LEDs) configured within an outer helmet and protective inner liner. The use of LDs and LEDs provides for a full coverage of the upper 1/3 of the head where commonly covered with stylized hair. The system automatically pauses therapy when the device is not in the correct head position and resumes treatment when the correct head position is re-established. At the end of the therapy cycle, the system signals that therapy is complete and the device will automatically turn off.
The device could be powered by internal rechargeable li-on battery, and it can also be supplied by specified external adapter with Input AC 100-240V, 50/60Hz and Output DC 5V, 2A.
5. Indications / Intended Use
The easy Hairfull is intended to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Classification of Skin Phototypes I to IV, and in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV.
6. Technical Characteristics in Comparison to Predicate Devices
| Predicate Device | Proposed Device | SE | |
|---|---|---|---|
| 510(K) | |||
| Number | K180617 | K202983 | |
| Manufacturer | Y&J BIO Co., Ltd. | Y&J BIO Co., Ltd. | YES |
| Device Name | Hair Up | easy Hairfull | |
| Clearance | |||
| Date: | June 1, 2018 | N/A | |
| Classification / | |||
| Regulation | Class 2 / 890.5500 | Class 2 / 890.5500 | YES |
| Product Code | OAP | OAP | YES |
| Intended Use | The Hair Up is intended to promote | ||
| hair growth in males with | |||
| androgenetic alopecia who have | |||
| Norwood Hamilton Classifications of | |||
| Ila to V and Fitzpatrick Classification | |||
| of Skin Phototypes I to IV, and in | |||
| females with androgenetic alopecia | |||
| who have Ludwig-Savin | |||
| Classifications of I-II and Fitzpatrick | |||
| Classification of Skin Phototypes I to | |||
| IV. | The easy Hairfull is intended to promote | ||
| hair growth in males with androgenetic | |||
| alopecia who have Norwood Hamilton | |||
| Classifications of IIa to V and Fitzpatrick | |||
| Classification of Skin Phototypes I to IV, | |||
| and in females with androgenetic | |||
| alopecia who have Ludwig-Savin | |||
| Classifications of I-II and Fitzpatrick | |||
| Classification of Skin Phototypes I to IV. | YES | ||
| Mode of | |||
| Operation | Low-level laser diodes and light | ||
| emitting diodes | Low-level laser diodes and light emitting | ||
| diodes | YES | ||
| Wavelength | 655 nm | 655 nm | YES |
Easy Hairfull is substantially equivalent to the following legally marketed predicate devices.
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easy Hairfull 510(k) Summary
| Number of
LDs/LEDs | LDs: 21
LEDs: 30 | LDs: 21
LEDs: 30 | YES |
|----------------------------|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|-----|
| Electrical
Requirements | Input: AC 100V ~ 240V (free voltage)
Frequency: 50Hz/60Hz
Power: 5V 2A | Input: AC 100V ~ 240V (free voltage)
Frequency: 50Hz/60Hz
Power: 5V 2A | YES |
| Battery Type | li-on battery | li-on battery | YES |
| How to use | Helmet system | Helmet system | YES |
| Treatment time | Each Treatment: 20-25 min
Total Treatment: every two days, for
16 weeks | Each Treatment: 20-25 min
Total Treatment: every two days, for 16 weeks | YES |
| Maximum
Power | 5mW | 5mW | YES |
6. Performance Data
Non-clinical tests: Measurement of wavelength and average output power, of treatment were performed. Testing conducted on the easy Hairfull shows that it refers to the relevant mandatory performance standards for laser products 21 CFR 1040.10 and 1040.11. Other performance, such as basic safety, etc, were tested using following consensus standards:
- Basic safety and essential performance of the easy Hairfull is tested and evaluated according to IEC 60601-1:2005.
- Effect to the device by electromagnetic disturbances were tested and evaluated according to the FDA-recognized consensus standard. IEC 60601-1-2:2014.
- -Safety of laser products is evaluated according to FDA-recognized consensus standard, IEC 60825-1: 2014.
- Photobiological safety of lamps and lamp systems is evaluated according to FDA-recognized consensus standard, IEC 62471:2006.
- -Risk management was recorded by referring to ISO 14971:2007.
- -Usability was documented referring to IEC 60601-1-6.
7. Substantial Equivalence
The intended use of the easy Hairfull is within the scope of the predicate devices. Easy Hairfull, from both a design and clinical perspective, uses similar or identical technology as the cited predicate devices and has the same intended uses. Based upon the predicted overall performance characteristics for the easy Hairfull, Y&J BIO Co., Ltd. believes that no significant differences exist in usage of its underlying technological principles between easy Hairfull and the cited predicate devices.
8. Conclusions
On the basis of the information provided in this Summary, Y&J BIO Co., Ltd. believes that the easy Hairfull is substantially equivalent to legally commercialized predicate devices for the purposes of this 510 (k) submission.