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.

AI/ML Overview

The provided text describes information about a 510(k) submission for a medical device called "AROMA GRAND". However, it does not contain any information regarding acceptance criteria or a study that proves the device meets those acceptance criteria in the context of clinical performance or diagnostic accuracy.

The document focuses on demonstrating substantial equivalence to a predicate device (VIKINI DIODE LASER SYSTEM) through non-clinical testing, primarily related to electrical safety, EMC, particular performance testing (likely referring to laser output specifications), and software verification.

Here's a breakdown of why I cannot answer most of your questions based on the provided text:

No clinical performance acceptance criteria: The document does not define specific clinical performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic device; or hair reduction percentage, lesion clearance rate for a therapeutic device) or set acceptance criteria for them.
No clinical study to prove acceptance criteria: Because no clinical performance acceptance criteria are mentioned, there is no corresponding study described to prove these criteria were met.
"Not applicable" for Clinical Testing: The document explicitly states "Clinical Testing: Not applicable," which further confirms the absence of a clinical study testing the device's efficacy/performance in human subjects for its intended use.

Therefore, I can only address the questions where relevant information is found in the text, primarily focusing on the non-clinical testing.

Here's an analysis of what information is available:

A table of acceptance criteria and the reported device performance

Clinical Performance: Not applicable/Not provided. The document does not define specific clinical performance acceptance criteria for its indications (hair removal, permanent hair reduction, treatment of benign vascular and pigmented lesions) nor report clinical performance against such criteria.

Non-Clinical Performance (General Safety and Technical Standards): The document reports compliance with several international standards. These standards implicitly contain acceptance criteria for the respective tests.

Acceptance Criteria (Implied by Standard Compliance)	Reported Device Performance
Biocompatibility:
- Cytotoxicity standards (ISO 10993-1)	Conducted and reported
- Sensitization standards (ISO 10993-1)	Conducted and reported
Electrical Safety:
- AAMI/ANSI/ES 60601-1:2005(R) 2012 and A1:2012	Complies with standard
Electromagnetic Compatibility (EMC):
- EN 60601-1-2:2015	Complies with standard
Laser Safety:
- IEC 60825-1:2014	Complies with standard
Particular Laser Performance:
- IEC 60601-2-22:2012	Complies with standard
Software Verification & Validation:
- FDA Guidance for Software in Medical Devices	Conducted and provided
Accuracy Testing (Energy Output & Spot Size):
- Does not deviate from tolerance/fixed value	Tested and complies

Sample size used for the test set and the data provenance
- For Non-Clinical Testing: The document does not specify sample sizes (e.g., number of devices tested) for the non-clinical tests.
- For Clinical/Performance Testing: "Clinical Testing: Not applicable." Therefore, no test set, sample size, or data provenance for clinical performance is provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- For Clinical/Performance Testing: "Clinical Testing: Not applicable." Thus, no experts were used to establish ground truth for a clinical test set.
- For Non-Clinical Testing: Not specified. Standard compliance is typically verified by testing laboratories.
Adjudication method for the test set
- For Clinical/Performance Testing: "Clinical Testing: Not applicable." No adjudication method described.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This is not an AI-assisted device. The AROMA GRAND is a laser surgical instrument. Therefore, an MRMC comparative effectiveness study regarding "human readers improving with AI" is not relevant and was not performed/described. "Clinical Testing: Not applicable."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device is not an algorithm; it is a physical laser device. Standalone algorithm performance is not applicable. "Clinical Testing: Not applicable."
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For Non-Clinical Testing: The "ground truth" for the non-clinical tests is established by the requirements and specifications of the respective international standards (e.g., specific thresholds for electromagnetic emissions, safety limits for laser output, pass/fail criteria for biocompatibility).
- For Clinical/Performance Testing: "Clinical Testing: Not applicable." No ground truth for clinical outcomes is discussed.
The sample size for the training set
- For Non-Clinical Testing: Not applicable. Non-clinical tests do not typically involve "training sets" in the machine learning sense.
- For Clinical/Performance Testing: "Clinical Testing: Not applicable."
How the ground truth for the training set was established
- For Non-Clinical Testing: Not applicable.
- For Clinical/Performance Testing: "Clinical Testing: Not applicable."

In summary, the provided FDA 510(k) letter and summary describe a device that is cleared based on substantial equivalence to a predicate device, supported by extensive non-clinical testing demonstrating compliance with safety and performance standards, but without any clinical performance studies on human subjects.

Summary

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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.

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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 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

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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

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Summary of Technological Characteristics

ITEM	PROPOSED DEVICE	PREDICATE DEVICE	Remark
	AROMA GRAND	VIKINI DIODE LASERSYSTEM
K number	K211637	K151232
Product Code	GEX	GEX	Same
Regulation	21 CFR 878.4810	21 CFR 878.4810	Same
Indications forUse	The AROMA GRAND isindicated for hair removal,permanent hair reduction and forthe treatment of benign vascularand pigmented lesions.Permanent hair reduction isdefined as the long-term, stablereduction in the number of hairsre-growing when measured at 6,9, and 12 months after thecompletion of a treatmentregimen.	The VIKINI DIODE LASERSYSTEM is indicated for hairremoval, permanent hairreduction and for the treatment ofbenign vascular and pigmentedlesions.Permanent hair reduction isdefined as the long-term, stablereduction in the number of hairsre-growing when measured at 6,9, and 12 months after thecompletion of a treatmentregimen.	Same
Configuration	Main Unit,Hand-piece	Main Unit,Hand-piece	Same
Principle ofOperation	Diode Laser	Diode Laser	Same
Laser Type	Diode Laser	Diode Laser	Same
LaserClassification	Class IV	Class IV	Same
LaserWavelength	808[nm]	808[nm]	Same
Spot Size	2.1[cm2] / 14*15[mm]	1.32[cm2] / 12*11[mm]	Analysis 1
Fluence	100[J/cm²]	120[J/cm²]	Analysis 2
Max. Output	100W/cm2	284W/cm2	Analysis 3
ITEM	PROPOSED DEVICE	PREDICATE DEVICE	Remark
Frequency	1-10[Hz]	1-10[Hz]	Same
Power	600W	600W	Same
Purse duration	10-350[ms]	5-625[ms]	Analysis 4
Cooling system	Water cooling	Water cooling	Same
Optical Guide	Sapphire Crystal	Sapphire Crystal	Same
Power Supply	100-240V, 50/60 Hz	100-240V, 50/60 Hz	Same
Dimensions	4806401,230[mm](LWH)	380400840 [mm]	Analysis 5
Weight	67[kg]	43[kg]
Electrical Safety	Comply withIEC 60601-1IEC 60601-2-22IEC 60825-1	Comply withIEC 60601-1IEC 60601-2-22IEC 60825-1	Same
EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2	Same

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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.

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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.

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.