K Number

Device Name

AROMA GRAND

Manufacturer

Daeju Meditech Engineering Co., Ltd.

Date Cleared

2021-09-03

(99 days)

Product Code

GEX

Regulation Number

878.4810

Intended Use

The AROMA GRAND is indicated for hair removal, permanent hair reduction and for the treatment of benign vascular and pigmented lesions. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

Device Description

The subject device. AROMA GRAND is a surgical device, which is intended for hair removal, permanent hair reduction on all skin tvpes (Fitzpatrick skin type I-VI). It utilizes a semiconductor diode as a laser source (808nm). The laser power is delivered to the treatment area via a laser hand-piece. The emission laser is activated by a footswitch.

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

K151232

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a laser device for hair removal and lesion treatment, focusing on the laser source and delivery mechanism. There is no mention of AI, ML, image processing, or any data-driven algorithms typically associated with AI/ML in medical devices. The performance studies listed are standard non-clinical tests for safety and effectiveness of a laser device.

Therapeutic

Yes
The device is indicated for the treatment of benign vascular and pigmented lesions, which falls under the definition of a therapeutic device designed to treat a medical condition.

Diagnostic

No
Explanation: The device, AROMA GRAND, is intended for hair removal, permanent hair reduction, and treatment of benign vascular and pigmented lesions. These are therapeutic and aesthetic purposes, not diagnostic ones.

SaMD (Software as a Medical Device)

The device description explicitly states it utilizes a semiconductor diode as a laser source and a laser hand-piece, indicating it is a hardware-based device.

IVD (In Vitro Diagnostic)

Based on the provided information, the AROMA GRAND device is not an In Vitro Diagnostic (IVD).

Here's why:

Intended Use: The intended use is for hair removal, permanent hair reduction, and treatment of benign vascular and pigmented lesions. These are all procedures performed directly on the patient's body.
Device Description: The device is described as a "surgical device" that utilizes a laser to treat the skin. This is consistent with a therapeutic or aesthetic device, not a diagnostic one.
Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The AROMA GRAND does not perform any such analysis of biological samples.

Therefore, the AROMA GRAND is a therapeutic/aesthetic device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The AROMA GRAND is indicated for hair removal, permanent hair reduction and for the treatment of benign vascular and pigmented lesions.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

Product codes

GEX

Device Description

The subject device, AROMA GRAND is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI).

It utilizes a semiconductor diode as a laser source (808nm). The laser power is delivered to the treatment area via a laser hand-piece. The emission laser is activated by a footswitch.

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical Testing Summary: The non-clinical testing results demonstrate that the subject device is as safe, as effective, and performs as well as the predicate device.
Biocompatibility Testing: The biocompatibility evaluation for the subject device was conducted in accordance with the guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The biocompatible testing including cytotoxicity, Sensitization are conducted according to the ISO 10993-1: 2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
Electrical Safety and electromagnetic Compatibility (EMC) testing: The device complies with the following standards: AAMI/ANSI/ES 60601-1:2005(R) 2012 and A1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance. EN 60601-1-2:2015 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests. IEC 60825-1:2014 Safety of laser products Part 1: Equipment classification and requirements.
Particular Performance Testing: Performance testing was conducted on the device according to IEC 60601-2-22:2012 Medical electrical equipment - Part 2-22: Particular requirements for the safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
Software Verification and Validation Testing: The software for this device was considered as a "Moderate" level of concern. Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Accuracy Testing: The accuracy test was conducted to verify that the energy output and spot size of the proposed laser system do not deviate the tolerance of the setting value of energy output or the fixed value of spot size. The non-clinical testing results demonstrate that the subject device is as safe, as effective, and performs as well as the predicate device.
Clinical Testing: Not applicable.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K151232

Reference Device(s)

Not Found

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 and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 3, 2021

Daeju Meditech Engineering Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620

Re: K211637

Trade/Device Name: Aroma Grand 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: July 30, 2021 Received: August 5, 2021

Dear April Lee:

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 and Part 809); 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,

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) K211637

Device Name AROMA GRAND

Indications for Use (Describe)

The AROMA GRAND is indicated for hair removal, permanent hair reduction and for the treatment of benign vascular and pigmented lesions.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing 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 CER 801 Subpart C)

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510(k) Summary

Submitter

DAEJU MEDITECH ENGINEERING Co., Ltd. SEONGUN KIM #501-504, HausD Sejong Tower, 26, Seongsu-il-ro 10gil, Seongdong-gu Seoul, South Korea 04793 Email: globalsales@daejumedi.co.kr Phone: +82-2-2208-0905

Device Information

Trade Name: AROMA GRAND
. Common Name: Powered laser surgical instrument
Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology
Product Code: GEX
Panel: General & Plastic Surgery
Regulation Number: 21 CFR §878.4810
Device Class: Class II
Date prepared: 08/19/2021

Predicate Device

Primary Predicate K151232, VIKINI DIODE LASER SYSTEM by ILOODA Company, Ltd.

Indications for use

The AROMA GRAND is indicated for hair removal, permanent hair reduction and for the treatment of benign vascular and pigmented lesions.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

Device Description

The subject device. AROMA GRAND is a surgical device, which is intended for hair removal, permanent hair reduction on all skin tvpes (Fitzpatrick skin type I-VI).

It utilizes a semiconductor diode as a laser source (808nm). The laser power is delivered to the treatment area via a laser hand-piece. The emission laser is activated by a footswitch.

Official Correspondent Withus Group Inc. April Lee 106 Superior,

Irvine. CA USA 92620 Email: withus6664@gmail.com Phone: +1-909-274-9971

Summary of Technological Characteristics

ITEM	PROPOSED DEVICE	PREDICATE DEVICE	Remark
	AROMA GRAND	VIKINI DIODE LASER
SYSTEM
K number	K211637	K151232
Product Code	GEX	GEX	Same
Regulation	21 CFR 878.4810	21 CFR 878.4810	Same
Indications for
Use	The AROMA GRAND is
indicated for hair removal,
permanent hair reduction and for
the treatment of benign vascular
and pigmented lesions.

Permanent hair reduction is
defined as the long-term, stable
reduction in the number of hairs
re-growing when measured at 6,
9, and 12 months after the
completion of a treatment
regimen. | The VIKINI DIODE LASER
SYSTEM is indicated for hair
removal, permanent hair
reduction and for the treatment of
benign vascular and pigmented
lesions.

Analysis 1 - Spot size

The spot size of the proposed device is larger than the spot size of the predicate device. Fluency (energy density) is a key factor in laser therapy. The fluency of the proposed device is not much different from the fluency of the predicate device. Therefore, the difference on spot size is considered would not raise any issues in safety and effectiveness.

Analysis 2-Fluence

The fluence for the proposed device is different from predicate device. However, this difference is very slight and performance testing has been conducted on the proposed device and the test result can comply with related standards requirement. Therefore, this difference does not raise issues of safety or effectiveness.

Analysis 3-Max. Output

The Max. Output for the proposed device is different from predicate device. The value is calculated as Power*Pulse duration/Spot Size. Power is the same, but differences occur due to Pulse durations and Spot Size. First of all, check the analysis 1 and analysis 4. Therefore, this difference does not raise issues of safety or effectiveness.

Analysis 4-Pulse duration

The Pulse duration is most important parameter how long time the energy will deliver to the patient s skin, it may affect the safety (too long action time) may burn patient`s skin. The Pulse duration of proposed device is 10-350ms, it's less than the Pulse duration of predicate device. That s means the proposed device could be consider as safety.

Analysis 5-Dimension and weight

The dimension and weight for the proposed device is different from predicate device. However, the dimension and weight difference are just in physical specification and this difference will not raise any issues in safety and effectiveness.

Non-clinical Testing Summary

The non-clinical testing results demonstrate that the subject device is as safe, as effective, and performs as well as the predicate device.

Biocompatibility Testing

The biocompatibility evaluation for the subject device was conducted in accordance with the guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The biocompatible testing including cytotoxicity, Sensitization are conducted according to the ISO 10993-1: 2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.

Electrical Safety and electromagnetic Compatibility (EMC)

Electrical safety and EMC testing were conducted on Diode Laser Hair Removal Machine. The device complies with the following standards

AAMI/ANSI/ES 60601-1:2005(R) 2012 and A1:2012 Medical electrical equipment Part 1: ● General requirements for basic safety and essential performance.
EN 60601-1-2:2015 Medical electrical equipment Part 1-2: General requirements for basic . safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
IEC 60825-1:2014 Safety of laser products Part 1: Equipment classification and requirements. ●

Particular Performance Testing

Performance testing was conducted on the device according to the following standard:

. IEC 60601-2-22:2012 Medical electrical equipment - Part 2-22: Particular requirements for the safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

Software Verification and Validation Testing

The software for this device was considered as a "Moderate" level of concern. Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

Accuracy Testing

The accuracy test was conducted to verify that the energy output and spot size of the proposed laser system do not deviate the tolerance of the setting value of energy output or the fixed value of spot size. The non-clinical testing results demonstrate that the subject device is as safe, as effective, and performs as well as the predicate device.

Clinical Testing

Not applicable.

Conclusion

Based on the comparison and analysis above, the proposed devices are determined to be as safe, as effective, and performs as well as the predicate device.