(101 days)
Not Found
No
The description focuses on the physical components (lasers, LEDs) and basic automated functions (pausing therapy based on head position), with no mention of AI or ML terms or capabilities.
Yes
The device is intended for the "promotion of hair growth in males with androgenetic alopecia", which is a therapeutic purpose.
No
The device is described as promoting hair growth and is compared to a predicate device with the same intended use. There is no mention of it being used to diagnose any 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." The performance studies also detail testing of hardware-related standards like laser safety and basic safety.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the device uses red visible laser diodes and red light emitting diodes applied to the upper 1/3 of the head for the promotion of hair growth. This is a direct application to the body, not an analysis of a specimen taken from the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, based on the provided text, this device falls under a different category of medical devices, likely a therapeutic device utilizing light energy.
N/A
Intended Use / Indications for Use
Promotion of hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Classification Skin Phototypes I to IV.
Product codes (comma separated list FDA assigned to the subject device)
OAP
Device Description
Hair Up shares great similarities with predicate device which is currently market cleared for promotion of hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Classification Skin Phototypes I to IV.
Both Hair Up and its predicate device both 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 for a full coverage of the upper 1/3 of the head where commonly covered with stylized hair. The system will automatically pause therapy when the correct head position is re-established. At the end of the therapy cycle, the system signals that therapy is complete and ready to be powered down.
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
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 (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 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.
- -Risk management was recorded by referring to ISO 14971:2007.
- Usability was documented referring to IEC 62366. -
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). To 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.
January 5, 2018
Y&J BIO Co., Ltd. % Ms. Mina Joo Manager BT Solutions Incorporated Unit 502, 148 Yeoksam-ro Seoul, 06249 Kr
Re: K172968
Trade/Device Name: Hair Up Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: December 6, 2017 Received: December 7, 2017
Dear Ms. 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 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/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.
David Krause -S
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
2
Indications for Use
510(k) Number (if known) K172968
Device Name Hair Up
Indications for Use (Describe)
Promotion of hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Classification 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 502, 148 Yuksamro, Gangnam-gu, Seoul, | |
| Republic of Korea | ||
| Tel) +82.2.538.9140 | ||
| Email) smanager@btsolutions.co.kr | ||
| Preparation Date: | September-22-2017 |
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 Predicate devices | ||
|---|---|---|
| Applicant | Device Name | 510(k) Number |
| Apira Science Inc. | igrow-II Hair Growth System | K141567 |
4. Device Description
4
Hair Up
510(k) Summary
Hair Up shares great similarities with predicate device which is currently market cleared for promotion of hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Classification Skin Phototypes I to IV.
Both Hair Up and its predicate device both 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 for a full coverage of the upper 1/3 of the head where commonly covered with stylized hair. The system will automatically pause therapy when the correct head position is re-established. At the end of the therapy cycle, the system signals that therapy is complete and ready to be powered down.
5. Indications / Intended Use
Promotion of hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Classification Skin Phototypes I to IV.
6. Technical Characteristics in Comparison to Predicate Devices
| Predicate Device | Proposed Device | |
|---|---|---|
| 510(K) Number | K141567 | Not Available |
| Manufacturer | Apira Science, Inc. | Y&J BIO Co., Ltd. |
| Device Name | igrow-II Hair Growth System | Hair Up |
| Clearance Date: | N/A | |
| Classification / | Class 2 / 890.5500 | Class 2 / 890.5500 |
| Regulation | ||
| Product Code | OAP | OAP |
| Intended Use | Promotion of hair growth in males with | Promotion of hair growth in males with |
| androgenetic alopecia who have | androgenetic alopecia who have | |
| Norwood Hamilton Classifications of IIa | Norwood Hamilton Classifications of IIa | |
| to V and Fitzpatrick Classification Skin | to V and Fitzpatrick Classification Skin | |
| Phototypes I to IV. | Phototypes I to IV. | |
| Mode of | Low-level laser diodes and light emitting | Low-level laser diodes and light emitting |
| Operation | diodes | diodes |
| Wavelength | 655 nm | 655 nm |
| Electrical | Input: AC 100V ~ 240V (free voltage) | Input: AC 100V ~ 240V (free voltage) |
| Requirements | Frequency: 50Hz/60Hz | Frequency: 50Hz/60Hz |
| Power: 5V 2A | Power: 5V 2A | |
| Maximum Power | 5 mW | 5 mW |
| How to use | Helmet system | Helmet system |
| Treatment time | 20-25 min | 20-25 min |
Hair Up is substantially equivalent to the following legally marketed predicate devices
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
5
Hair Up
510(k) Summary
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.
- -Risk management was recorded by referring to ISO 14971:2007.
- Usability was documented referring to IEC 62366. -
7. Substantial Equivalence
The intended use of the Hair Up is within the scope of the predicate devices. Hair Up, from both a design and clinical perspective, uses similar or identical technology as the cited predicate device and has the same intended uses. Based upon the predicted overall performance characteristics for the Hair Up, Y&J BIO Co., Ltd. believes that no significant differences exist in usage of its underlying technological principles between Hair Up 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 Hair Up is substantially equivalent to legally commercialized predicate devices for the purposes of this 510 (k) submission.