(57 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on the IPL technology and basic electrical components.
No
The device is indicated for hair removal and permanent reduction in hair regrowth, which are cosmetic purposes, not therapeutic.
No
The device is an IPL hair removal system, which is a therapeutic device designed to reduce hair growth, not diagnose medical conditions.
No
The device description explicitly states it is a physical device utilizing Intense Pulsed Light (IPL) technology and includes hardware components like the IPL device itself, a power supply, and a user manual. It is described as a "small over-the-counter device" with specific dimensions and weight. While software verification and validation are mentioned in the performance studies, this refers to the software controlling the hardware, not a standalone software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the removal and permanent reduction of unwanted hair on the body. This is a cosmetic or therapeutic application, not a diagnostic one.
- Device Description: The device uses Intense Pulsed Light (IPL) to target hair follicles. This is a physical interaction with the body, not an analysis of biological samples.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a disease, condition, or state of health by examining samples taken from the human body.
IVD devices are specifically designed to perform tests on biological samples (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This IPL hair removal device does not perform such tests.
N/A
Intended Use / Indications for Use
The IPL Hair Removal Device OBT-02 Version is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime. The device is used for adults.
Product codes
OHT
Device Description
IPL Hair Removal, Model: OBT-02, a small over-the-counter device, is a home-use device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. A personal Light-Based Hair Removal System. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. Emission is by finger switch. Device includes IPL DEVICE, Power supply and User manual. It is used AC Powered (100-240 V AC). The weight of the device is 220g, and the size is 150 x 75 x 45mm (H"W"D). The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Intense Pulsed Light
Anatomical Site
Not Found
Indicated Patient Age Range
adults
Intended User / Care Setting
home-use device
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)
6.1 IPL Hair Removal, Model: OBT-02 has been evaluated the safety and performance by lab bench testing as following:
- Electrical safety test according to AAMI/ANSI ES60601-1:2005(R) 2012 and A1:2012, IEC 60601-1-11:2015 and IEC 60601-2-57:2011 standards
- Electromagnetic compatibility test according to IEC 60601-1-2:2014 standard
- Biocompatibility test according to ISO10993-5; ISO 10993-10 Standard
- Software verification and validation test according to the requirements of the FDA "Guidance for PreMarket Submissions and for Software Contained in Medical Devices"
- Bench performance testing conducted to demonstrate that the pulse duration, output energy, maximum fluence, and wavelength do not deviate in excess of the allotted 10% tolerance
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and 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.
November 18, 2021
Glan Electronics Co., Ltd. % Iris Fung Official Correspondent SGS-CSTC Standards Technical Services Co., LTD 198 Kezhu Road, ScienTech Park Guangzhou Economic & Tech Development District GuangZhou, Guangdong China
Re: K213041
Trade/Device Name: IPL Hair Removal, Model: OBT-02 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: OHT Dated: September 14, 2021 Received: September 22, 2021
Dear Iris Fung:
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 and Part 809); 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,
Purva Pandya 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) K213041
Device Name IPL Hair Removal, Model: OBT-02
Indications for Use (Describe)
The IPL Hair Removal Device OBT-02 Version is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime. The device is used for adults.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Residential Use That is NOT STD 44A Subject to Review | On-site Tier Construction is STD 44A Subject to Review |
|---|---|
| -------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------- |
| | 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
Sponsor: Glan Electronics Co., Ltd. Subject Device: IPL Hair Removal, Model: OBT-02 510(k) number: K213041
Date of the summary prepared: November 2, 2021
510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
Submitter's Information 1.
Sponsor
- � Company Name: Glan Electronics Co., Ltd.
- Address: A4 Building, Huafa Industrial Zone, Fuyuan 1st Road, Xinhe Community, Fuyong � Town, Bao'an District, Shenzhen, China
- Phone: 0086-755-28910840 �
- Contact Person (including title): LISA PAN �
- � E-mail: lisa@glancap.com / lisa@glanelectronics.com
Application Correspondent:
- SGS-CSTC Standards Technical Services Co., Ltd. �
- Address: 198 KEZHU Road, SCIENTECH Park Guangzhou Economic & Technology � Development District, Guangzhou, Guangdong, CHINA
- Contact Person: Iris Funq �
- Tel: + 86-32136908 �
- � Email: Iris.Funq@sqs.com/jianda-lee@foxmail.com
Subject Device Information 2.
- � Trade Name: IPL Hair Removal, Model: OBT-02
- Light Based Over-The-Counter Hair Removal � Common Name:
- Laser Surgical Instrument For Use In General And Plastic � Classification name: Surgery And In Dermatology
- General & Plastic Surgery � Review Panel:
- OHT � Product Code:
- Regulation Class: 2 �
- 878.4810 � Regulation Number:
4
3. Predicate Device Information
| Sponsor | Medical Device Branch of
Zhangzhou Easepal Industrial
Co.,Ltd. | STETIC MEDICAL
AESTHETICS
DEVELOPMENT
(SHENZHEN) CO., LTD | CyDen Limited. |
|-------------------|----------------------------------------------------------------------|--------------------------------------------------------------------|-----------------------------------------------|
| Device Name | IPL Salon Hair Reduction
System | DUO | iPulse SmoothSkin Gold
Hair Removal System |
| 510(k) Number | K181568 | K161565 | K160968 |
| Product Code | OHT | ONF, OHT | OHT, GEX |
| Regulation Number | 878.4810 | 878.4810 | 878.4810 |
| Regulation Class | 2 | 2 | 2 |
4. Device Description
IPL Hair Removal, Model: OBT-02, a small over-the-counter device, is a home-use device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. A personal Light-Based Hair Removal System. Permanent hair reduction is defined as the longterm stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. Emission is by finger switch. Device includes IPL DEVICE, Power supply and User manual. It is used AC Powered (100-240 V AC). The weight of the device is 220g, and the size is 150 x 75 x 45mm (H"W"D). The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.
5. Intended Use / Indications for Use
The IPL Hair Removal Device OBT-02 Version is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime. The device is used for adults.
6. Test Summary
6.1 IPL Hair Removal, Model: OBT-02 has been evaluated the safety and performance by lab bench testing as following:
- � Electrical safety test according to AAMI/ANSI ES60601-1:2005(R) 2012 and A1:2012, IEC 60601-1-11:2015 and IEC 60601-2-57:2011 standards
- � Electromagnetic compatibility test according to IEC 60601-1-2:2014 standard
- � Biocompatibility test according to ISO10993-5; ISO 10993-10 Standard
5
Glan Electronics Co., Ltd. Sponsor: Subject Device: IPL Hair Removal, Model: OBT-02 510(k) number: K213041
- Software verification and validation test according to the requirements of the FDA � "Guidance for PreMarket Submissions and for Software Contained in Medical Devices"
- Bench performance testing conducted to demonstrate that the pulse duration, output energy, maximum fluence, and wavelength do not deviate in excess of the allotted 10% tolerance
6.2 Materials
There is one part of patient- directly contracting components in the subject device as the following list.
| Component of Device
Requiring
Biocompatibility | Material of
Component | Body Contact
Category
(ISO 10993-1) | Contact Duration
(ISO 10993-1) |
|------------------------------------------------------|--------------------------|-------------------------------------------|-----------------------------------|
| IPL Lamp output window
and case enclosure | ABS | Surface-contacting
device: skin | Maximum 30
minutes (