(85 days)
No
The description focuses on the physical components (LDs, LEDs) and basic automated functions (pausing therapy based on head position). There is no mention of AI, ML, image processing, or data analysis for diagnosis, treatment planning, or outcome prediction.
Yes
The device is intended to promote hair growth in individuals with androgenetic alopecia, which is a medical condition, making it a therapeutic device.
No
The device is intended to promote hair growth, not to diagnose a condition.
No
The device description explicitly states it consists of hardware components: 21 red visible laser diodes (LDs) and 30 red light emitting diodes (LEDs) configured within an outer helmet and protective inner liner.
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 detect diseases, conditions, or infections.
- Device Function: The Hair Up device uses laser and LED light therapy applied externally to the scalp to promote hair growth. It does not analyze any biological samples.
- Intended Use: The intended use clearly states it's for promoting hair growth in individuals with androgenetic alopecia, not for diagnosing or detecting a condition through in vitro testing.
The device is a therapeutic device that applies energy to the body for a medical purpose.
N/A
Intended Use / Indications for Use
The Hair Up 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
OAP
Device Description
The Hair Up is basically an identical device with the 510(k)-cleared device Hair Up (K172968). A new 510(k) clearance is applied this time with a new indications for use (IFU).
Subject device, Hair up and its primary predicate device consist 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 full coverage of the upper 1/3 of the head which is commonly covered with stylized hair. The system will automatically pause therapy until the correct head position is re-established. At the end of the therapy cycle, the subject device Hair Up signals that therapy is complete and the device is ready to be powered down.
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
Not Found
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
Non-clinical tests: Measurement of wavelength and average output power, of treatment were performed. Testing conducted on the Hair up 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 Hair Up 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.
- Biological evaluation of medical devices is tested and evaluated according to ISO 10993--5: 2009 and ISO 10993-10:2010.
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA acronym and the agency's name are in blue.
June 1, 2018
Y&J BIO Co, Ltd., Ms. Mina Joo Assistant Manager BT Solutions, Inc. 91-14 Seolleung-ri #402 Gangnam-gu, Seoul, 06150 Kr
Re: K180617
Trade/Device Name: Hair Up Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: March 6, 2018 Received: March 8, 2018
Dear Mina Joo:
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, 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 (OS) regulation (21 CFR Part 820);
1
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 comprehensive regulatory information about mediation-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
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Indications for Use
510(k) Number (if known) K180617
Device Name Hair Up
Indications for Use (Describe)
The Hair Up 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: | No. C-413, Munjeong Hyundai Knowledge Center 1 |
| 7, Beobwon-ro 11-gil, Songpa-gu, Seoul, | |
| Republic of Korea | |
| Tel) +82-3400-0325 | |
| Contact Person: | Mina Joo, BT Solutions, Inc. |
| Address: | Unit 402, 91-14 Seolleung-ro, Seoul, Republic of |
| Korea | |
| Tel) +82.2.538.9140 | |
| Email) smanager@btsolutions.co.kr | |
| Preparation Date: | June-1-2018 |
| 2. Device Name and Code | |
| Device Trade Name: | Hair Up |
| 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 (ODE) |
3. Predicate Devices
Hair Up is substantially equivalent to the following device Table 5.1 Primary Predicate device
| Applicant | Device Name | 510(k) Number |
|---|---|---|
| Apira Science Inc. | iGrow-II Hair Growth System | K140931 |
| Applicant | Device Name | 510(k) Number |
|---|---|---|
| Apira Science Inc. | iGrow-II Hair Growth System | K141567 |
| Slinph Technologies | ||
| Co., Ltd. | iHelmet Hair Growth System | K162782 |
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Hair Up 510(k) Summary
4. Device Description
The Hair Up is basically an identical device with the 510(k)-cleared device Hair Up (K172968). A new 510(k) clearance is applied this time with a new indications for use (IFU).
Subject device, Hair up and its primary predicate device consist 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 full coverage of the upper 1/3 of the head which is commonly covered with stylized hair. The system will automatically pause therapy until the correct head position is re-established. At the end of the therapy cycle, the subject device Hair Up signals that therapy is complete and the device is ready to be powered down.
5. Indications / Intended Use
The Hair Up 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
| Primary Predicate Device | Reference Device 1 | Reference Device 2 | Proposed Device | |
|---|---|---|---|---|
| 510(K) Number | K140931 | K141567 | K162782 | Not Available |
| Manufacturer | Apira Science, Inc. | Apira Science, Inc. | Slinph Technologies Co., Ltd. | Y&J BIO Co., Ltd. |
| Device Name | iGrow-II Hair Growth System | iGrow-II Hair Growth System | iHelmet Hair Growth System | Hair Up |
| Clearance Date: | December 5, 2014 | August 21, 2014 | April 4, 2017 | N/A |
| Classification / Regulation | Class 2 / 890.5500 | Class 2 / 890.5500 | Class 2 / 890.5500 | Class 2 / 890.5500 |
| Product Code | OAP | OAP | OAP | OAP |
| Intended Use | The iGrow-II Hair Growth System is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV. | The iGrow-II Hair Growth System is indicated 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. | iHelmet Hair Growth System (Model: LTD200S) 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 | The Hair Up 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 |
Hair Up is substantially equivalent to the following legally marketed predicate devices
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Hair Up 510(k) Summary
| Mode of Operation | Low-level laser diodes and light emitting diodes | Low-level laser diodes and light emitting diodes | Low-level laser diodes and light emitting diodes | Low-level laser diodes and light emitting diodes |
|---|---|---|---|---|
| Wavelength | 655 nm | 655 nm | $650 nm\pm10 nm$ | 655 nm |
| 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 | Input: DC 5V, 2A, USB charger; | |||
| Internal lithium battery | ||||
| Battery Voltage 3.7V | ||||
| Battery Capacity 3000mAh , 11.1Wh | Input: AC 100V ~ 240V (free voltage) | |||
| Frequency: 50Hz/60Hz | ||||
| Power: 5V 2A | ||||
| How to use | Helmet system | Helmet system | Helmet system | Helmet system |
| Treatment time | 20-25 min | 20-25 min | 20-35 min | 20-25 min |
| Classifications IIa - V and for both, Fitzpatrick Classification of Skin Phototypes of I - IV. | of I-II and Fitzpatrick Classification of Skin Phototypes I to IV. |
Reference Devices: 1. Apira Science, Inc's iGrow-II Hair Growth System (K141567)*
*This reference device is referred, of which the technical aspects such as number of diodes, treatment time and intended use for males are same to those of the Hair Up.
-
- Slinph Technologies Co., Ltd.'s iHelmet Hair Growth System (K162782) **
**This reference device is referred, of which the intended use for both males and females is same, the fluence and irradiance are comparable to those of the Hair Up.
- Slinph Technologies Co., Ltd.'s iHelmet Hair Growth System (K162782) **
6. Performance Data
Non-clinical tests: Measurement of wavelength and average output power, of treatment were performed. Testing conducted on the Hair up 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 Hair Up 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.
- Biological evaluation of medical devices is tested and evaluated according to ISO 10993--5: 2009 and ISO 10993-10:2010.
6
Hair Up
510(k) Summary
- Risk management was recorded by referring to ISO 14971:2007. -
- -Usability was documented referring to IEC 62366.
7. Conclusions
The technological characteristics of the subject device Hair Up are comparable to those of the predicates for comparable indications for use. Thus, subject device Hair Up is concluded to be substantially equivalent to the predicates.