← Product Code [GEX](/productcode/GEX) · K211637 # AROMA GRAND (K211637) _Daeju Meditech Engineering Co., Ltd. · GEX · Sep 3, 2021 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K211637 ## Device Facts - **Applicant:** Daeju Meditech Engineering Co., Ltd. - **Product Code:** [GEX](/productcode/GEX.md) - **Decision Date:** Sep 3, 2021 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## 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 Story Aroma Grand is a Class IV semiconductor diode laser surgical system (808nm) for hair removal and treatment of benign vascular/pigmented lesions. Device comprises a main unit and a laser hand-piece with a sapphire crystal optical guide. Physician/clinician operates device via footswitch to deliver laser energy to treatment area. Water cooling system manages thermal output. Device output parameters (fluence, pulse duration, spot size) are controlled by the user to target hair follicles or vascular/pigmented structures. Clinical benefit includes permanent hair reduction and lesion treatment. Device is intended for professional use in clinical settings. ## Clinical Evidence No clinical data. Bench testing only. Performance testing included electrical safety (IEC 60601-1, IEC 60601-2-22), EMC (IEC 60601-1-2), laser safety (IEC 60825-1), and biocompatibility (ISO 10993-1). Accuracy testing verified energy output and spot size within tolerance. ## Technological Characteristics Diode laser (808nm); Class IV; 600W power; 1-10Hz frequency; 10-350ms pulse duration; 2.1cm2 spot size; water cooling; sapphire crystal optical guide. Complies with IEC 60601-1, IEC 60601-2-22, IEC 60825-1, and IEC 60601-1-2. Biocompatibility per ISO 10993-1. ## Regulatory 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 - VIKINI DIODE LASER SYSTEM ([K151232](/device/K151232.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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)
| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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 {4}------------------------------------------------ # 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.

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. | Same | | Configuration | Main Unit,
Hand-piece | Main Unit,
Hand-piece | Same | | Principle of
Operation | Diode Laser | Diode Laser | Same | | Laser Type | Diode Laser | Diode Laser | Same | | Laser
Classification | Class IV | Class IV | Same | | Laser
Wavelength | 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 | 480*640*1,230[mm]
(L*W*H) | 380*400*840 [mm] | Analysis 5 | | Weight | 67[kg] | 43[kg] | | | Electrical Safety | Comply with
IEC 60601-1
IEC 60601-2-22
IEC 60825-1 | Comply with
IEC 60601-1
IEC 60601-2-22
IEC 60825-1 | Same | | EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same | {5}------------------------------------------------ {6}------------------------------------------------ ### 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. {7}------------------------------------------------ ### 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. --- **Source:** [https://fda.innolitics.com/device/K211637](https://fda.innolitics.com/device/K211637) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com