(54 days)
Not Found
No
The summary describes a standard IPL hair removal device with no mention of AI or ML capabilities in its operation, description, or performance studies.
No.
The device is intended for the removal of unwanted hair, which is a cosmetic purpose rather than a therapeutic one addressing a disease or condition.
No
This device is intended for hair removal, which is a therapeutic or cosmetic purpose, not for diagnosing a 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 Intense Pulsed Light technology for hair removal. While it mentions software documentation and validation, the core function and description are hardware-based.
No, 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 about a person's health. This testing is done outside of the body.
- Device Function: The JOVS Hair Removal Device uses Intense Pulsed Light (IPL) to reduce hair growth directly on the body and/or face. It does not involve analyzing any biological samples.
- Intended Use: The stated intended use is "removal of unwanted body and/or facial hair," which is a cosmetic or aesthetic purpose, not a diagnostic one.
The information provided clearly describes a device that interacts with the body externally for a non-diagnostic purpose.
N/A
Intended Use / Indications for Use
Hand-held IPL device (JOVS Hair Removal Device) is an over-the-counter device intended for removal of unwanted body and/or facial hair.
Product codes
OHT
Device Description
Hand-held IPL device (JOVS 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. Hand-held IPL device (JOVS Hair Removal Device) includes JR5C-E, JR5C-W, JR5C-OG, JR5-E, JR5-W, JR5-OG. 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 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)
The following performance data are provided in support of the substantial equivalence determination:
- 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
- IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-11 Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical
- 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. System validation testing demonstrated that all software requirement specifications have been met and all software hazards have been mitigated to acceptable risk levels.
- Usability testing has been performed to, and passed, the following standards:
- IEC 60601-1-6 Medical electrical equipment -Part 1-6: General requirements for safety -Collateral standard: Usability
Based on the above performance, the Hand-held IPL device (JOVS 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
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 27, 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: K220645
Trade/Device Name: Hand-held IPL device (JOVS 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: March 2, 2022 Received: March 4, 2022
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.
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 (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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220645
Device Name
Hand-held IPL device (JOVS Hair Removal Device)
Indications for Use (Describe)
Hand-held IPL device (JOVS 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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3
510(k) Summary - K220645
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 Hair Removal Device)
Model(s): JR5C-E, JR5C-W, JR5C-OG, JR5-E, JR5-W, JR5-OG
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 | |
| SHENZHEN JVK MEDICAL | ||
| INSTRUMETS CO., LTD | Hand-held IPL device (JOVS | |
| Graphene Hair Removal Device) | K214113 |
Device description 4.
Hand-held IPL device (JOVS Hair Removal Device) is a personal, light-based, hair reduction device.
4
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.
Hand-held IPL device (JOVS Hair Removal Device) includes JR5C-E, JR5C-W, JR5C-OG, JR5-E, JR5-W, JR5-OG. Their intended use, performance, structure design and operation are basically identical, with the different color appearance.
5. Indications for Use
Hand-held IPL device (JOVS 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)
Hand-held IPL device (JOVS 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.
Hand-held IPL device (JOVS Hair Removal Device) is compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance:
-
K160968(Primary Predicate Device), " IPulse SmoothSkin Gold Hair Removal Device ", manufactured by " CyDen Ltd " in Swansea, United Kingdom
-
K214113, "Hand-held IPL device (JOVS Graphene Hair Removal Device)", manufactured by "SHENZHEN JVK MEDICAL INSTRUMETS CO., LTD " in Guangdong, China
| Comparison
Elements | Subject Device | Primary Predicate
Device 1
(K160968) | Predicate Device 2
(K214113) | Remark |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Device name | Hand-held IPL
device (JOVS Hair
Removal Device) | IPulse SmoothSkin
Gold Hair Removal
Device | Hand-held IPL
device (JOVS Hair
Graphene
Removal Device) | -- |
| Model | JR5C-E, JR5C-W,
JR5C-OG, JR5-E,
JR5-W, JR5-OG | -- | JOC-910-Yellow
JOC-910-Emerald | -- |
| Comparison
Elements | Subject Device | Primary Predicate
Device 1
(K160968) | Predicate Device 2
(K214113) | Remark |
| Classification
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 | Hand-held
IPL
device (JOVS 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 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. | SE |
| Source Energy | Supplied by external
adapter | Supplied by
external adapter | Supplied by external
adapter | SE |
| Comparison
Elements | Subject Device | Primary Predicate
Device 1
(K160968) | Predicate Device 2
(K214113) | Remark |
| Technology | Intense Pulsed Light
(IPL) | Intense Pulsed Light
(IPL) | Intense Pulsed Light
(IPL) | SE |
| 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 | 590nm〜1200nm | SE |
| Energy density | 1.835.14 J/cm2 | 3-6J/cm2 | 2.95.4 J/cm2 | SE |
| Spot size | 3.5cm2 | 3cm2 | 3.4cm2 | SE |
| Output energy | 6.418 J | 9.0-18.0J | 9.818.4 J | SE |
| Pulse duration | 5.59.5 ms | 210ms | 5.5~9.5 ms | SE |
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6
7. Performance Data
The following performance data are provided in support of the substantial equivalence determination.
1) 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
-
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
7
Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
-
IEC 60601-2-83 Medical Electrical Equipment -- Part 2-83: Particular Requirements For The Basic Safety And Essential Performance Of Home Light Therapy Equipment
2) 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.
3)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 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 Hair Removal Device) is considered to be substantially equivalent to its predicate device.