(88 days)
Not Found
No
The description focuses on IPL technology and a skin proximity sensor, with no mention of AI or ML.
Yes
The device is intended for the permanent reduction of hair growth, which is a physiological change for a non-cosmetic purpose, meeting the definition of a therapeutic device.
No
The device is intended for hair removal, a cosmetic application, not for diagnosing any medical condition.
No
The device description explicitly details hardware components such as a Xenon Lamp, skin proximity sensor, treatment window head, adaptor, and goggles, and describes its physical dimensions and mechanism of action involving light emission.
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, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The IPL Hair Removal Device works by applying light energy directly to the skin to target hair follicles. It does not analyze any biological samples taken from the body.
- Intended Use: The intended use is for the removal of unwanted body hair, which is a cosmetic or aesthetic purpose, not a diagnostic one.
The device is a medical device, but it falls under a different category than IVDs. It's a light-based device for hair removal.
N/A
Intended Use / Indications for Use
The IPL Hair Removal Device (Model: TB-1755) is an Over the Counter device intended for the removal of unwanted body hair.
Product codes
OHT
Device Description
IPL Hair Removal Device Model: TB-1755, a small over-the-counter 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. Emission activation is by finger switch. Device includes a treatment window head, an adaptor and goggles. The size of the device is about 185 x 72.4 x 69.2mm (H x W x D). The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.
The device contains a Xenon Lamp and a skin proximity sensor to detect appropriate skin contact. If the IPL Hair Removal Device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered a pulse emitting.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
back, legs &arms, armpits and bikini areas, except the face and other delicate areas.
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)
IPL Hair Removal Device has been evaluated the safety and performance by lab bench testing according to the following standards:
- IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 2005+A1:2012
- IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests, 2014
- 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
- IEC 60601-2-57 Medical electrical equipment -Part 2-57: Particular requirements for the basic safety and essential performance of non-laser source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
- ISO 10993-5:2009/(R) 2014, 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.
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff
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.
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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 is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. % Jet Li Regulation Manager Guangzhou KEDA Testing Tech Co., Ltd. 6F, No.1 TianTai road, Science City, LuoGang District GuangZhou, CN
February 15, 2019
Re: K183217
Trade/Device Name: IPL 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 ONF Dated: November 10, 2018 Received: November 19, 2018
Dear Jet Li:
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.
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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.
Image /page/1/Figure/5 description: This image shows a digital signature and associated information. The signature is from Neil R Ogden -S, and the date is 2019.02.15 at 08:56:30 -05'00'. The signature is for Binita S. Ashar, M.D., M.B.A., F.A.C.S., who is the Director of the Division of Surgical Devices, Office of Device Evaluation, and Center for Devices and Radiological Health.
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
IPL Hair Removal Device (Model: TB-1755)
Indications for Use (Describe)
The IPL Hair Removal Device (Model: TB-1755) is an Over the Counter device intended for the removal of unwanted body 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
K183217 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 878.4810.
Submitter Information 1.
- � Company Name: Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.
- � Establishment Registration Number: Applying
- � Address: 7/F, Marina Bay Centre A, South of Xinhua Road, Bao'an Centre Area, Xin'an Street Bao'an District, Shenzhen, China.
- � Phone: +86 755-3366 2222
- � FAX: +86 755-3366 8880
- Contact Person (including title): Aaron Zhai (Engineer) �
- � E-mail: bz@touchbeauty.com
2. Application Correspondent
- Company Name: Guangzhou KEDA Testing Tech Co., Ltd. �
- � Address: 6F, No.1 TianTai road, Science City, LuoGang District, GuangZhou City, China
- � Contact Person: Mr. Jet Li
- Title: Regulation Manager �
- � Tel: +86-20-22325619
- � Email: med-jl @foxmail.com
Subject Device Information 3.
- � Type of 510(k) submission: Traditional
- � Common Name: Light Based Over-The-Counter Hair Removal
- � Trade Name: IPL Hair Removal Device
- Classification Name: Laser surgical instrument for use in general and plastic surgery and in �
4
dermatology
- � Review Panel: General & Plastic Surgery
- � Product Code: OHT
- � Regulation Number: 21 CFR 878.4810
- � Regulation Class: 2
4. Predicate Device Information
| Sponsor | Trade Name | 510(k) number | Product Code | Approval Date |
|---|---|---|---|---|
| CyDen Limited | iPulse SmoothSkin Gold | |||
| Hair Removal System | K160968 | OHT | April 14, 2016 | |
| Shen Zhen | ||||
| CosBeauty Co., Ltd | Perfectsmooth | K161428 | OHT | March 23, 2017 |
5. Device Description
IPL Hair Removal Device Model: TB-1755, a small over-the-counter 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. Emission activation is by finger switch. Device includes a treatment window head, an adaptor and goggles. The size of the device is about 185 x 72.4 x 69.2mm (H x W x D). The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.
The device contains a Xenon Lamp and a skin proximity sensor to detect appropriate skin contact. If the IPL Hair Removal Device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered a pulse emitting.
Intended Use 6.
The IPL Hair Removal Device (Model: TB-1755) is an Over the Counter device intended for the removal of unwanted body hair.
7. TestSummary
IPL Hair Removal Device has been evaluated the safety and performance by lab bench testing according to the following standards:
-
IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 2005+A1:2012
5
-
IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests, 2014
-
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
-
IEC 60601-2-57 Medical electrical equipment -Part 2-57: Particular requirements for the basic safety and essential performance of non-laser source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
-
ISO 10993-5:2009/(R) 2014, 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.
-
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff
8. Comparison to Predicate De vice
Compare with predicate devices, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between subject device and predicate devices do not raise any new questions of safety or effectiveness.
| Elements of
| Comparison | Subject Device | Primary Predicate Device 1 | Predicate Device 2 | Verdict |
|---|---|---|---|---|
| Manufacturer | Touchbeauty Beauty & | |||
| Health (Shenzhen) Co., | ||||
| Ltd. | CyDen Limited. | ShenZhen CosBeauty | ||
| Co., Ltd | -- | |||
| Product | ||||
| Name | IPL Hair Removal | |||
| Device | iPulse SmoothSkin Gold Hair | |||
| Removal System | Perfectsmooth | -- | ||
| 510(K) No. | Applying | K160968 | K161428 | -- |
| Elements of | ||||
| Comparison | Subject Device | Primary Predicate Device 1 | Predicate Device 2 | Verdict |
| Indications | ||||
| for Use | The IPL Hair Removal | |||
| Device (Model: TB- |
- is an Over the
Counter device intended
for the removal of
unwanted body 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 Joy Version is
an over-the-counter
device intended for
removal of unwanted
hair such as but not
limited to small areas
such as underarm and
facial hair below the
chin line and large
areas such as legs. | SE
Note 1 |
| IFU Type | Over-The-Counter | Over-The-Counter | Over-The-Counter | SE |
| Classification
Product Code | OHT | OHT | OHT | SE |
| Device Type | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | SE |
| Device Design | | | | |
| Power source | an external power supply | AC Mains | an external power supply | SE
Note 2 |
| Light source | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp | SE |
| Wavelength | 510nm1100nm | 510nm1100nm | 475nm~1200nm | SE
Note 2 |
| Spot Size | 3.1 cm² | 3 cm² | 4.5 cm² | SE
Note 2 |
| Max. Fluence
(J/cm²) | 3.8-5.2 J/cm² | 3-6 J/cm² | 4.7 J/cm² | SE
Note 2 |
| Pulse duration | 3 milliseconds | 2-10 milliseconds | 11-13 milliseconds | SE
Note 2 |
| Output energy | 12-16 J | 9-18 J |