(26 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard IPL technology and hardware.
No.
The indications for use specify hair removal (permanent hair reduction), which is generally considered a cosmetic procedure rather than a therapeutic one aimed at treating a disease or condition.
No
Explanation: The device is indicated for hair removal (permanent hair reduction) and generates light energy for treatment, not for diagnosing conditions.
No
The device description explicitly states it is an "Intense Pulsed Light (IPL) system" consisting of a "console containing the power unit and control electronics" and "Applicators/hand pieces". This indicates significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "hair removal (permanent hair reduction)". This is a therapeutic or cosmetic procedure performed directly on the patient's body.
- Device Description: The device is an Intense Pulsed Light (IPL) system that generates light energy for treatment. This is a physical intervention applied externally.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
The SmoothCool HR System operates on the patient's skin to affect hair follicles, which is a direct treatment, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The SmoothCool HR System is indicated for hair removal (permanent hair reduction).
Product codes
GEX
Device Description
The SmoothCool HR System is an Intense Pulsed Light (IPL) system used hair removal (Permanent hair reduction) in the area of dermatology. The system consists of a console containing the power unit and control electronics with control and display panel including software. Applicators/hand pieces are connected to the system in order to generate light energy for treatment in the waveband 420-950 nm. Four different hand pieces are attached with the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
To validate the control of the risks, the following tests were performed.
- Energy Output Test
- Button Operation Test
Key Metrics
Not Found
Predicate Device(s)
SmoothCool HR System (K213484)
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). On the left side of the image 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 4, 2023
Jeisys Medical Inc % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 18881 Von Karman Ave. STE 160 Irvine, California 92612
Re: K223685
Trade/Device Name: SmoothCool HR System 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: GEX Dated: December 7, 2022 Received: December 9, 2022
Dear Priscilla Chung:
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.
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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,
Jianting Wang -S
Jianting Wang Acting 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
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Indications for Use
510(k) Number (if known) K223685
Device Name SmoothCool HR System
| Indications for Use (Describe) |
|---|
| --------------------------------------- |
The SmoothCool HR System is indicated for hair removal (permanent hair reduction).
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
(K223685)
Dec 30, 2022
1. Submitted by:
Jeisys Medical Inc 307, 308, 401, Daeryung Techno Town 8th, 96, Gamasan-ro, Geumcheon-Gu, Seoul, 08501, Republic of Korea
2. US Agent/ Official Correspondent:
Priscilla Chung
LK Consulting Group USA, Inc. 18881 Von Karman Ave STE 160 Irvine, CA 92612 Tel: 714.202.5789 Fax: 714.409.3357 Email: juhee.c@LKconsultingGroup.com
3. Device Name:
| - Trade Name | : SmoothCool HR System |
|---|---|
| - Classification | : Class II |
| - Classification Name | : Powered Laser Surgical Instrument |
| - Product Code | : GEX |
| - Regulation Number | : 21 CFR 878.4810 |
| - Review Panel | : General Hospital |
4. Predicate Device:
- SmoothCool HR System (K213484) by Jeisys Medical Inc.
5 Device Description:
The SmoothCool HR System is an Intense Pulsed Light (IPL) system used hair removal (Permanent hair reduction) in the area of dermatology. The system consists of a console containing the power unit and control electronics with control and display panel including
4
software. Applicators/hand pieces are connected to the system in order to generate light energy for treatment in the waveband 420-950 nm. Four different hand pieces are attached with the system.
6 Indications for Use Statement
The SmoothCool HR System is indicated for hair removal (permanent hair reduction).
7 Substantial Equivalence Discussion:
| Proprietary | Subject Device | Primary Predicate Device |
|---|---|---|
| Manufacturer | Jeisys Medical Inc. | Jeisys Medical Inc. |
| Device Name | SmoothCool HR System | SmoothCool HR System |
| 510(k) | ||
| Number | K223685 | K213484 |
| Device | ||
| Classification | ||
| Name | Laser surgical instrument for use in general and | |
| plastic surgery and in dermatology | Laser surgical instrument for use in general and | |
| plastic surgery and in dermatology | ||
| Product Code | GEX | GEX |
| Regulation | ||
| Number | 878.4810 | 878.4810 |
| Intended Use | The SmoothCool HR System is indicated for | |
| hair removal (permanent hair reduction). | The SmoothCool HR System is indicated for | |
| hair removal (permanent hair reduction). | ||
| Components | • Main Console | |
| • Hand Pieces: | ||
| 420nm(S) Handpiece | ||
| 560nm(S) Handpiece | ||
| 700nm(S) Handpiece | ||
| 700nm(L) Handpiece | ||
| • Filters | ||
| 800, 700, 640, 590, 560, 545(V), 530, 530(D), | ||
| 530(s), 500, 420(s)nm | ||
| • Eyes Protector | ||
| • Power Cord | • Main Console | |
| • Hand Pieces: | ||
| 420nm(S) Handpiece | ||
| 560nm(S) Handpiece | ||
| 700nm(S) Handpiece | ||
| 700nm(L) Handpiece | ||
| • Filters | ||
| 800, 700, 560, 530, 530(s), 420(s)nm | ||
| • Eyes Protector | ||
| • Power Cord | ||
| Power Output | Up to 65 J/cm2 | Up to 65 J/cm2 |
| Sterile | No | No |
7.1.Comparison Chart
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7.2. Substantial Equivalence Discussion
The indications for use and the technological characteristics of the subject device are the same as the predicate device, the unmodified device (K213484). The modification is adding more filters. The power output and also the range of the filter remained the same. We also performed risk analysis and verification/validation tests per modification, and the test results support that the modifications do not raise a question in safety and performance.
8. Technological Characteristics:
The SmoothCool HR System and the predicate devices in the market have the substantially equivalent technological characteristics. Risks associated with the changes were identified and appropriate design controls implemented to mitigate the risks.
To validate the control of the risks, the following tests were performed.
| No | Test |
|---|---|
| 1 | Energy Output Test |
| 2 | Button Operation Test |
9. Conclusion:
Based on the information provided in this special 510(k), the SmoothCool HR System is substantially equivalent to the predicate devices.