Not Found
No
The description focuses on hardware components (IPL lamp, sensors) and basic logic (proximity/pigmentation checks, cycle count). There is no mention of AI/ML algorithms, training data, or complex decision-making beyond simple sensor inputs.
No
The device is described as an over-the-counter device intended for the removal and permanent reduction of unwanted hair, which is generally considered a cosmetic use rather than a therapeutic medical treatment.
No
The device is intended for hair removal and permanent hair reduction. It does not diagnose any medical conditions or diseases.
No
The device description clearly outlines hardware components such as a treatment window head, facial adaptor, battery charger/AC cord, Quartz Xenon Lamp, skin proximity sensor, and skin pigmentation sensor. It also mentions physical characteristics like weight and size, and relies on Intense Pulsed Light (IPL) technology, which is a hardware-based modality. While software verification and validation are mentioned, this is for the software contained within the hardware device, not a standalone software product.
Based on the provided information, the DUO (Model: IPL-HH380-IT) is not an In Vitro Diagnostic (IVD) device.
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.
- DUO's Intended Use: The DUO is intended for the removal and permanent reduction of unwanted body and facial hair. This is a cosmetic or aesthetic purpose, not a diagnostic one.
- Device Description: The device uses Intense Pulsed Light (IPL) applied to the skin surface to target hair follicles. It does not involve the analysis of any biological specimens.
Therefore, the DUO falls under the category of a medical device, specifically a light-based hair removal system, but it is not an IVD.
N/A
Intended Use / Indications for Use
The DUO (Model: IPL-HH380-IT) is an over the Counter device intended for the removal of unwanted body and/or facial hair in adults. The DUO is also intended for permanent reduction in unwanted hair. Permanent hair reduction is 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 regimen.
Product codes
ONF, OHT
Device Description
DUO, Model: IPL-HH380-IT,a small over-the-counter,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.Emission activation is by finger switch.Device includes a treatment window head,a facial adaptor and battery charger/AC cord.lt is used AC Powered(100-240 V AC; 50/60 Hz).The weight of the device is 280g, and the size is 130 x 70 x 30 mm (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 Quartz Xenon Lamp,a skin proximity sensor and a skin pigmentation sensor to detect appropriate skin tones. If the DUO is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the DUO will not trigger a pulse. The spot size (treatment area) in the DUO device is 3 cm². When the lamp had been subjected to operation of 300000 cycles, then the indicator light on the device is flashing at the frequency of 2Hz , it means that the device life has reached the end, the device stops working.
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
Adults
Intended User / Care Setting
Home-use device, Over the Counter
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)
DUO, Model: IPL-HH380-IT has been evaluated the safety and performance by lab bench testing as following:
- Electrical safety test according to IEC 60601-1 and IEC 60601-2-57 standards
- Electromagnetic compatibility test according to IEC 60601-1-2 standard
- Software verification and validation test according to the requirements of the FDA "Guidance for PreMarket Submissions and for Software Contained in Medical Devices"
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 for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the caduceus symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 1, 2016
Stetic Medical Aesthetics Development (Shenzhen) Co., Ltd. % Iris Fung Official Correspondent SGS-CSTC Standards Technical Services Co., Ltd. 198 Kezhu Road. Scientech Park Guangzhou Guangzhou. CN
Re: K161565 Trade/Device Name: Duo 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: ONF, OHT Dated: May 30, 2016 Received: June 6, 2016
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. 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
1
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 Part 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation , please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Christopher J. Ronk -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) K161565
Device Name DUO, Model: IPL-HH380-IT
Indications for Use (Describe)
The DUQ (Model: IPL-HH380-IT) is an over the Counter device intended for the removal of unwanted body and/or facial hair in adults. The DUO is also intended for permanent reduction in unwanted hair. Permanent hair reduction is 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 regimen.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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.
1. Submitter's Information
Sponsor
- � Company Name: STETIC MEDICAL AESTHETICS DEVELOPMENT (SHENZHEN) CO. , LTD
- � Address: 10-11th Floor, Bensi Building, New High-Tech-Park, Ganli Village, Buji District, Shenzhen, China
- Phone: 86-755 6121 8197 �
- � Fax: 86-755 2598 1606
- � Contact Person (including title): Yejuan
- E-mail: info@steticsensebeauty.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: Ms. Iris Fung
- Tel: +86-20-32136908 �
- Email: Iris.Fung@sgs.com �
Subject Device Information 2.
- DUO, Model: IPL-HH380-IT � Trade Name:
- DUO Common Name: �
- Powered Light Based Non-Laser Surgical Instrument With Classification name: �
- Thermal Effect
- General & Plastic Surgery Review Panel: �
- ONF � Product Code:
- 2 Regulation Class: �
- 878.4810 Regulation Number: �
Page 13 of 59 Report by STETIC MEDICAL AESTHETICS DEVELOPMENT (SHENZHEN) CO. ,LTD
STETIC MEDICAL AESTHETICS DEVELOPMENT (SHENZHEN) CO. ,LTD Sponsor: Subject Device: DUO, Model: IPL-HH380-IT
510(k) submission report (V1.0), Chapter 6 510(k) Summary File No.:
3. Predicate Device Information
| Sponsor | Shaser, Inc. | EL Global Trade Ltd. |
|---|---|---|
| Device Name | Lumena FH Hair Removal System | Sensi Light Mini |
| 510(k) Number | K140631 | K140527 |
| Product Code | ONF | OHT |
| Regulation Number | 878.4810 | 878.4810 |
| Regulation Class | 2 | 2 |
4. Device Description
DUO, Model: IPL-HH380-IT,a small over-the-counter,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
4
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,a facial adaptor and battery charger/AC cord.lt is used AC Powered(100-240 V AC; 50/60 Hz).The weight of the device is 280g, and the size is 130 x 70 x 30 mm (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 Quartz Xenon Lamp,a skin proximity sensor and a skin pigmentation sensor to detect appropriate skin tones. If the DUO is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the DUO will not trigger a pulse. The spot size (treatment area) in the DUO device is 3 cm². When the lamp had been subjected to operation of 300000 cycles, then the indicator light on the device is flashing at the frequency of 2Hz , it means that the device life has reached the end, the device stops working.
5. Intended Use / Indications for Use
The DUO (Model: IPL-HH380-IT) is an over the Counter device intended for the removal of unwanted body and/or facial hair in adults. The DUO is also intended for permanent reduction in unwanted hair. Permanent hair reduction is 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 regimen.
6. Design
DUO, Model: IPL-HH380-IT,a small over-the-counter,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.Emission activation is by finger switch. Device includes a treatment window head,a facial adaptor
Page 14 of 59 Report by STETIC MEDICAL AESTHETICS DEVELOPMENT (SHENZHEN) CO. LTD
STETIC MEDICAL AESTHETICS DEVELOPMENT (SHENZHEN) CO. ,LTD Sponsor: Subject Device: DUO, Model: IPL-HH380-IT
File No.: 510(k) submission report (V1.0), Chapter 6 510(k) Summary
and battery charger/AC cord.lt is used AC Powered(100-240 V AC; 50/60 Hz).The weight of the device is 280g, and the size is 130 x 70 x 30 mm (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 Quartz Xenon Lamp, a skin proximity sensor and a skin pigmentation sensor to detect appropriate skin tones. If the DUO is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the DUO will not trigger a pulse. The spot size (treatment area) in the DUO device is 3 cm². When the lamp had been subjected to operation of 300000 cycles, then the indicator light on the device is flashing at the frequency of 2Hz , it means that the device life has reached the end, the device stops working.
7. Materials
There are two user 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) |
|------------------------------------------------------|--------------------------|-------------------------------------------|-----------------------------------|
| Housing | PC 2805 | Surface-contacting
device: skin | Maximum 30
minutes(7.7J
Level 2:>8.5J
Level 3:>9.4J
Level 4:>10.5J
Level 5:>12J |
| Output energy with facial adaptor | Level 1:>4.0J
Level 2:>4.7J
Level 3:>5.4J
Level 4:>5.9J
Level 5:>6.7J |
| Emitted Light Spectrum | 480nm~1200nm Max |
| Pulse Duration: | [