SmoothCool HR System

K213484 · Jeisys Medical, Inc. · GEX · Apr 20, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K213484
• Device Name: SmoothCool HR System
• Applicant: Jeisys Medical, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 20, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SmoothCool HR System is indicated for hair removal (permanent hair reduction).

Device Story

Intense Pulsed Light (IPL) system for permanent hair reduction; consists of console with power unit, control electronics, display panel, and software; utilizes interchangeable handpieces (420nm, 560nm, 700nm) and filters to generate light energy; operated by clinicians in dermatological settings; light energy targets melanin in hair follicles; output controlled via console interface; benefits patient through stable, long-term hair reduction.

Clinical Evidence

Bench testing only. Verification and validation testing performed on modified components, including energy output testing and electrical safety/EMC testing per EN 60601-1, EN 60601-1-2, and EN 60601-2-22 standards.

Technological Characteristics

IPL system; console-based with interchangeable handpieces and filters (420nm, 530nm, 560nm, 700nm, 800nm); energy output up to 65 J/cm2; electrical safety per EN 60601-1, EN 60601-1-2, and EN 60601-2-22; software-controlled; non-sterile.

Indications for Use

Indicated for hair removal (permanent hair reduction) in dermatology.

Regulatory Classification

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.

Predicate Devices

• SmoothCool (K082911)
• Stellar M22 for Intense Pulsed Light (IPL) and Laser system (K193500)

Submission Summary (Full Text)

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April 20, 2022

Jeisys Medical Inc % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 18881 Von Karman Ave. STE 160 Irvine, California 92612

Re: K213484

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: October 18, 2021 Received: October 29, 2021

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 mediation-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 ([e-mail]) or phone [phone] 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 Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K213484

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)

> Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(K) SUMMARY

(K213484)

Apr 20, 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 Fax: [phone] Tel: [phone] Email: [e-mail]

#### 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 (K082911) by Jeisys Medical Inc.
- Stellar M22 for Intense Pulsed Light (IPL) and Laser system (K193500) by Lumenis Ltd.

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#### Device Description: ഗ

SmoothCool HR System is an Intense Pulsed Light (IPL) system used for 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. Four different hand pieces are offered with the system.

#### Indications for Use Statement e

The SmoothCool HR System is indicated for hair removal (permanent hair reduction).

| Proprietary | Subject Device | Primary Predicate Device | Reference Device | | • Main Console | • Main Console | • Main Console |
|----------------------------------|-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Jeisys Medical Inc. | Jeisys Medical Inc. | Lumenis Ltd. | Components | • Hand Pieces:<br>420nm(S) Handpiece<br>560nm(S) Handpiece<br>700nm(S) Handpiece<br>700nm(L) Handpiece<br>• Filters<br>800, 700, 560, 530, 420nm<br>• Eyes Protector<br>• Power Cord | • Hand Pieces:<br>560nm(S) Handpiece<br>700nm(S) Handpiece<br>700nm(L) Handpiece<br>• Filters<br>700, 560nm<br>• Eyes Protector<br>• Power Cord | • IPL Handpiece<br>400-1200 nm<br>• ResurFX Handpiece<br>1565 nm<br>• Multi-Spot Nd:YAG Handpiece<br>1064 nm<br>• Q-Switched Nd:YAG Handpiece<br>1064 nm |
| Device Name | SmoothCool | SmoothCool | Stellar M22 for Intense Pulsed<br>Light (IPL) and Laser system | Power Output | Up to 65 J/cm2 | Up to 65 J/cm2 | • IPL Handpiece<br>Up to 56 J/cm2<br>• Multi-Spot Nd:YAG Handpiece<br>10~225 J/cm2<br>• Q-Switched Nd:YAG Handpiece<br>0.9~14 J/cm2 |
| 510(k)<br>Number | - | K082911 | K193500 | Software | Software Validation | Software Validation | Software Validation |
| Device<br>Classification<br>Name | Laser surgical instrument for<br>use in general and plastic<br>surgery and in dermatology | Laser surgical instrument for use<br>in general and plastic surgery and<br>in dermatology | Laser surgical instrument for use in<br>general and plastic surgery and in<br>dermatology | Sterile | No | No | No |
| Product Code | GEX | GEX | GEX | | | | |
| Regulation<br>Number | 878.4810 | 878.4810 | 878.4810 | | | | |
| Intended Use | The SmoothCool HR System is<br>indicated for hair removal<br>(permanent hair reduction). | The SmoothCool HR System is<br>indicated for hair removal<br>(permanent hair reduction). | The subject Stellar M22 has<br>connection capability with the<br>following available treatment<br>handpieces, for multi-application<br>treatment options. All handpieces<br>are designed for aesthetic and<br>dermatological<br>skin procedure applications, as<br>follows:<br>□ The Intense Pulsed Light (IPL)<br>handpiece with a spectrum of<br>400-1200 nm (with 9<br>different filters) is indicated for:<br>o Benign epidermal lesions,<br>including dyschromia,<br>hyperpigmentation, melasma, and<br>ephelides (freckles)<br>o Cutaneous lesions, including<br>warts, scars and striae<br>o Benign cutaneous vascular | | | | |
| | | lesions, including port wine stains,<br>hemoangiomas, facial,truncal and<br>leg telangiectasias, erythema of<br>rosacea, angiomas and spider<br>angiomas, poikiloderma of Civatte,<br>leg veins and venous<br>malformations<br>o Removal of unwanted hair and to<br>effect stable long term, or<br>permanent* hair reduction in skin<br>types I-V through selective<br>targeting of melanin in hair follicles<br>o Mild to moderate inflammatory<br>Acne (Acne vulgaris)<br>□ The Nd:YAG Laser handpiece<br>with a wavelength of 1064 nm<br>(Multi-Spot Nd:YAG) is<br>indicated for:<br>o The coagulation and hemostasis<br>of vascular lesions and soft tissue,<br>including the treatment and<br>clearance of superficial and deep<br>telangiectasias (venulectasias) and<br>reticular veins (0.1-4.0 mm.<br>diameter) of the leg<br>o The removal of unwanted hair<br>and to effect table long term, or<br>permanent* hair reduction in skin<br>types I-V through selective<br>targeting of melanin in hair follicles<br>o The non-ablative treatment of<br>facial wrinkles<br>□ ResurFX module and<br>handpiece, with wavelength of<br>1565 nm, is indicated for:<br>o Use in dermatological procedures<br>requiring fractional skin resurfacing<br>and coagulation of soft tissue<br>□ The Q-Switched Nd:YAG<br>Laser Handpiece with a<br>wavelength of 1064 nm is<br>indicated for:<br>o Removal of dark tattoos<br>o Treatment of pigmented lesions<br>*Note<br>Permanent hair reduction is defined<br>as long-term, stable reduction in the<br>number of hairs regrowing when<br>measured at 6, 9, and 12 months<br>after completion of treatment<br>regime. | | | | | |

#### Substantial Equivalence Discussion: 7

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The indications for use and the technological characteristics of the subject device is the same as the predicate device, the unmodified device (K082911). Modifications are the addition of handpieces and filters. We identified a reference device which has the same indications for use (hair removal) and encompasses the wavelength range of the subject device.

We performed risk analysis and verification/validation tests per modifications, 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 | Standard |
|----|---------------------------|---------------------------------------------|
| 1 | Energy Output Test | - |
| 2 | Electrical Safety and EMC | EN 60601-1<br>EN 60601-1-2<br>EN 60601-2-22 |

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## 9. Conclusion:

Based on the information provided in this special 510(k), the SmoothCool HR System is substantially equivalent to the predicate devices.