(88 days)
Not Found
No
The summary describes a standard IPL hair removal device with no mention of AI or ML capabilities in its operation or features.
No
The device is described as a hair reduction device, not one used for treating a disease or disorder. Its intended use is for cosmetic hair removal.
No
The device is intended for hair removal, not for diagnosing any medical condition.
No
The device description explicitly states it is a "Hand-held IPL device" containing a "Xenon lamp" and powered by an "external power adapter," indicating it is a physical hardware device that uses light-based technology for hair removal.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens from the human body. This device is used directly on the body and/or face for hair removal.
- The intended use is for hair removal. IVD devices are used for diagnosis, monitoring, or screening of diseases or conditions by testing samples like blood, urine, or tissue.
- The device description clearly states it's a personal, light-based, hair reduction device. This aligns with a cosmetic or aesthetic device, not a diagnostic one.
The information provided describes a device that interacts with the body externally to achieve a physical effect (hair reduction), which is not the function of an IVD.
N/A
Intended Use / Indications for Use
The Hand-held IPL device (JOVS Graphene Hair Removal Device) is an over-the-counter device intended for removal of unwanted body and/or facial hair.
Product codes
OHT
Device Description
The Hand-held IPL device (JOVS Graphene Hair Removal Device) is a personal, light-based, hair reduction device. The device contains a Xenon lamp and provides hair reduction by Intense Pulsed Light (IPL) technology and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device is for single-person use only.
The Hand-held IPL device (JOVS Graphene Hair Removal Device) includes JOC-910-Yellow and JOC-910-Emerald. Their intended use, performance, structure design and operation are basically identical, with the different color appearance.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body and/or facial hair.
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)
- Biocompatibility Testing: The biocompatibility evaluation for the body-contacting components of the Hand-held IPL device (JOVS Graphene Hair Removal Device) has been conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices –Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on June 16, 2016", as recognized by FDA. The testing has been performed to, and passed, including:
- ISO 10993-5:2009, Biological Evaluation of Medical Devices -Part 5: Tests for In Vitro Cytotoxicity
- ISO 10993-10:2010, Biological Evaluation of Medical Devices -Part 10: Tests for Irritation and Skin Sensitization
- Electrical Safety and Eye Safety: Electrical safety and Eye safety testing has been performed to, and passed, the following standards:
- IEC 60601-1-2 Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
- A IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
- A IEC 60601-1-11 Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
- A IEC 60601-2-83 Medical Electrical Equipment - Part 2-83: Particular Requirements For The Basic Safety And Essential Performance Of Home Light Therapy Equipment
-
Software Verification and Validation: Software documentation consistent with moderate level of concern is submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications have been met and all software hazards have been mitigated to acceptable risk levels.
-
Usability: Usability testing has been performed to, and passed, the following standards:
- A IEC 60601-1-6 Medical electrical equipment -- Part 1-6: General requirements for safety -Collateral standard: Usability
Summary: Based on the above performance as documented in this application, the Hand-held IPL device (JOVS Graphene Hair Removal Device) is found to have a safety and effectiveness profile that is similar to the predicate device.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 5, 2022
Shenzhen Qianyu Technology Co., Ltd. % Klem Hou RA manager Guangzhou Tianke Testing Technology Service Co., Ltd. Room 106-1, 1st Floor, Building A, No. 1, Xin'an Road Yonghe Economic Zone, Huangpu District Guangzhou, Guangdong 510000 China
Re: K214113
Trade/Device Name: Hand-held IPL device (JOVS Graphene Hair Removal Device) 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
Dear Klem Hou:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 28, 2022. Specifically, FDA is updating this SE Letter to correct an error in the 510(k) summary as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Purva Pandya, OHT4: Office of Surgical and Infection Control Devices, at 240-402-9979 or Purva.Pandya@fda.hhs.gov.
Sincerely,
Purva U. Pandya -S
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
1
Image /page/1/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" in a smaller font below.
March 28, 2022
Shenzhen Qianyu Technology Co., Ltd. % Klem Hou RA manager Guangzhou Tianke Testing Technology Service Co., Ltd. Room 106-1, 1st Floor, Building A, No. 1, Xin'an Road Yonghe Economic Zone, Huangpu District Guangzhou, Guangdong 510000 China
Re: K214113
Trade/Device Name: Hand-held IPL device (JOVS Graphene Hair Removal Device) 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: December 16, 2021 Received: December 30, 2021
Dear Klem Hou:
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.
2
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 (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(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Purva U. Pandya -S
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
3
Indications for Use
510(k) Number (if known) K214113
Device Name
Hand-held IPL device (JOVS Graphene Hair Removal Device)
Indications for Use (Describe)
The Hand-held IPL device (JOVS Graphene Hair Removal Device) is an over-the-counter device intended for removal of unwanted body and/or facial hair.
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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4
510(k) Summary
1. Submitter
Shenzhen Qianyu Technology Co., Ltd
Room 1002, Building A2, KeXing Science Park, No.15 Keyuan Road, Nanshan District,
Shenzhen, Guangdong Province, China
Post code: 518100
Tel.: +86 158 1380 6593
Klem Hou
RA manager
Tel: +86 178 7557 1727
Email: pharmaklem@outlook.com
2. Device
Name of Device: Hand-held IPL device (JOVS Graphene Hair Removal Device)
Model(s): JOC-910-Yellow, JOC-910-Emerald
Common or Usual Name: Light Based Over-The-Counter Hair Removal
Classification Name: Laser surgical instrument for use in general and plastic surgery and in
dermatology
Regulatory Class: II
Product Code: OHT
Regulation Number: 21 CFR 878.4810
3. Predicate device(s)
| Manufacturer | Predicate Device | 510(k) Number |
|---|---|---|
| CyDen Ltd | IPulse SmoothSkin Gold Hair | |
| Removal Device | K160968 | |
| Zhongshan Bisen Plastic Electronic | ||
| Products Co., Ltd. | IPL Hair Removal Device | K212314 |
4. Device description
The Hand-held IPL device (JOVS Graphene Hair Removal Device) is a personal, light-based, hair
5
K214113
reduction device. The device contains a Xenon lamp and provides hair reduction by Intense Pulsed Light (IPL) technology and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device is for single-person use only.
The Hand-held IPL device (JOVS Graphene Hair Removal Device) includes JOC-910-Yellow and JOC-910-Emerald. Their intended use, performance, structure design and operation are basically identical, with the different color appearance.
5. Indications for Use
The Hand-held IPL device (JOVS Graphene Hair Removal Device) is an over-the-counter device intended for removal of unwanted body and/or facial hair.
6. Comparison of Technological Characteristics with the Predicate Device(s)
The Hand-held IPL device (JOVS Graphene Hair Removal Device) has the same intended use, mode of action and similar operational characteristics as the predicate devices. Any minor differences between the subject device and the listed predicate devices do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate device for its intended use.
The Hand-held IPL device (JOVS Graphene Hair Removal Device) is compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance: 1)K160968(Primary Predicate Device), " IPulse SmoothSkin Gold Hair Removal Device ", manufactured by " CyDen Ltd " in Swansea, United Kingdom
2)K212314, " IPL Hair Removal Device ", manufactured by " Zhongshan Bisen Plastic Electronic Products Co., Ltd." in Guangdong, China
| Comparison
Elements | Subject Device | Primary Predicate
Device 1
(K160968) | Predicate
Device 2
(K212314) | Remark | |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|----|
| Device name | Hand-held IPL device
(JOVS Graphene Hair
Removal Device) | IPulse
Gold Hair
Device | SmoothSkin
Removal | IPL Hair
Removal | -- |
| Model | JOC-910-Yellow
JOC-910-Emerald | -- | BZ-0721 | -- | |
| Comparison
Elements | Subject Device | Primary Predicate
Device 1
(K160968) | Predicate
Device 2
(K212314) | Remark | |
| Regulation
Name | Laser surgical
instrument for use in
general and plastic
surgery and
dermatology | Laser Surgical
Instrument For Use In
General And Plastic
Surgery And
In Dermatology | Laser surgical
instrument for
use in general
and plastic
surgery and
dermatology | SE | |
| Product code | OHT | OHT | OHT | SE | |
| Regulation
number | 878.4810 | 878.4810 | 878.4810 | SE | |
| Class | II | II | II | SE | |
| Prescription
or OTC | OTC | OTC | OTC | SE | |
| Indications
for use | The Hand-held
IPL
device
(JOVS
Graphene
Hair
Removal Device) is an
over-the-counter
device intended
for
removal of unwanted
body and/or facial hair. | The iPulse SmoothSkin
Gold Hair Removal
System is indicated for
the removal of
unwanted hair. The
iPulse SmoothSkin
Gold is also indicated
for the permanent
reduction in hair
regrowth, defined as
the long-term, stable
reduction in the number
of hairs regrowing
when measured at 6, 9
and 12 months after the
completion of a
treatment regime. | The IPL Hair
Removal
Device is an
over-the-
counter device
intended for
removal of
unwanted body
and/or facial
hair. | SE | |
| Source
Energy | Supplied by external
adapter | Supplied by external
adapter | Supplied by
external adapter | SE | |
| Technology | Intense Pulsed Light
(IPL) | Intense Pulsed Light
(IPL) | Intense Pulsed
Light (IPL) | SE | |
| Comparison
Elements | Subject Device | Primary Predicate
Device 1
(K160968) | Predicate
Device 2
(K212314) | Remark | |
| Energy
medium | Xenon lamp | Xenon lamp | Xenon lamp | SE | |
| Pulsing
Control | Finger switch | Finger switch | Finger switch | SE | |
| Delivery
device | Direct illumination to
tissue | Direct illumination to
tissue | Direct
illumination to
tissue | SE | |
| Wavelength | 590nm - 1200nm | 510 - 1100nm | 510nm - 1100nm | SE | |
| Energy
density | 2.9 - 5.4 J/cm2 | 3 - 6 J/cm2 | 1.5 - 3.0 J/cm2 | SE | |
| Spot size | 3.4 cm2 | 3 cm2 | 4 cm2 | SE | |
| Output
energy | 9.8 - 18.4 J | 9.0 - 18.0J | 6.0 - 11.8 J | SE | |
| Pulse
duration | 5.5 - 9.5 ms | 2 - 10 ms | 10.4 ms | SE | |
6
7
7. Performance Data
The following performance data are provided in support of the substantial equivalence determination.
1) Biocompatibility Testing
The biocompatibility evaluation for the body-contacting components of the Hand-held IPL device (JOVS Graphene Hair Removal Device) has been conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices –Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on June 16, 2016", as recognized by FDA. The testing has been performed to, and passed, including:
-
ISO 10993-5:2009, Biological Evaluation of Medical Devices -Part 5: Tests for In Vitro Cytotoxicity
-
ISO 10993-10:2010, Biological Evaluation of Medical Devices -Part 10: Tests for Irritation and Skin Sensitization
8
2) Electrical Safety and Eye Safety
Electrical safety and Eye safety testing has been performed to, and passed, the following standards:
- IEC 60601-1-2 Medical electrical equipment –Part 1-2: General requirements for basic safety > and essential performance -Collateral standard: electromagnetic compatibility
- A IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
- A IEC 60601-1-11 Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
- A IEC 60601-2-83 Medical Electrical Equipment - Part 2-83: Particular Requirements For The Basic Safety And Essential Performance Of Home Light Therapy Equipment
4) Software Verification and Validation
Software documentation consistent with moderate level of concern is submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications have been met and all software hazards have been mitigated to acceptable risk levels.
5)Usability
Usability testing has been performed to, and passed, the following standards:
- A IEC 60601-1-6 Medical electrical equipment -- Part 1-6: General requirements for safety -Collateral standard: Usability
Summarv
Based on the above performance as documented in this application, the Hand-held IPL device (JOVS Graphene Hair Removal Device) is found to have a safety and effectiveness profile that is similar to the predicate device.
8. Conclusions
Based on the comparison of intended use, design, materials and performance, the Hand-held IPL device (JOVS Graphene Hair Removal Device) is considered to be substantially equivalent to its predicate device.