K Number

Device Name

SmoothCool HR System

Manufacturer

Jeisys Medical Inc

Date Cleared

2022-04-20

(173 days)

Product Code

GEX

Regulation Number

878.4810

Intended Use

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

Device Description

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K082911

Reference Devices

K193500

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard IPL system with control electronics and software, but there is no mention of AI, ML, image processing, or any data-driven algorithms that would indicate the use of AI/ML. The performance studies focus on energy output and electrical safety, not algorithmic performance.

Therapeutic

No
The device is indicated for hair removal (permanent hair reduction), which is generally considered a cosmetic procedure and not a therapeutic medical treatment aiming to cure or alleviate a disease or medical condition.

Diagnostic

No
The device is indicated for hair removal, which is a treatment, not a diagnosis. It generates light energy for treatment and does not mention any diagnostic capabilities.

SaMD (Software as a Medical Device)

The device description explicitly states it is an "Intense Pulsed Light (IPL) system" consisting of a console, power unit, control electronics, and applicators/hand pieces, all of which are hardware components. While it includes software, it is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, the SmoothCool HR System is not an IVD (In Vitro Diagnostic) device.

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, not a diagnostic test performed on biological samples.
Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. The SmoothCool HR System does not perform this function.

Therefore, the SmoothCool HR System is a therapeutic/cosmetic device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

GEX

Device Description

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.

No	Test	Standard
1	Energy Output Test	-
2	Electrical Safety and EMC	EN 60601-1
EN 60601-1-2
EN 60601-2-22

Key Metrics

Not Found

Predicate Device(s)

SmoothCool (K082911) by Jeisys Medical Inc.

Reference Device(s)

K193500

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.

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.

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 (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 Quality Center for Devices and Radiological Health

Enclosure

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: 714.409.3357 Tel: 714.202.5789 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 (K082911) by Jeisys Medical Inc.
Stellar M22 for Intense Pulsed Light (IPL) and Laser system (K193500) by Lumenis Ltd.

Device Description: ഗ

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

Substantial Equivalence Discussion: 7

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
EN 60601-1-2
EN 60601-2-22

9. Conclusion:

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