(221 days)
No
The summary describes a laser surgical instrument with user-controlled parameters and a cooling system. There is no mention of AI, ML, image processing, or data training/testing, which are typical indicators of AI/ML technology in medical devices.
Yes
The device is described as a laser surgical instrument used for incision, excision, ablation, and vaporization of soft tissue, as well as for the treatment of various skin conditions like acne and wrinkles, all of which are therapeutic interventions.
No
The device description clearly states its purpose as a laser surgical instrument for incision, excision, ablation, and vaporization of soft tissue, and for treating skin conditions like acne and wrinkles. These are all treatment functions, not diagnostic ones. There is no mention of the device analyzing or identifying disease.
No
The device description explicitly details hardware components such as a diode laser module, main body with touch LCD, hand-piece, foot switch, and a dynamic cooling device (DCD). It is a physical laser surgical instrument, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The NOABLE LASER is a surgical instrument that uses a laser to directly interact with and modify skin tissue. It is used for procedures like incision, excision, ablation, and vaporization.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It directly treats the patient's tissue.
- Intended Use: The intended use clearly describes surgical procedures on the skin, not diagnostic testing of biological samples.
Therefore, the NOABLE LASER falls under the category of a surgical laser device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue, Treatment of back acne Treatment of atrophic acne scars Treatment of facial wrinkles Treatment of mild to moderate acne vulgaris Treatment of Sebaceous Hyperplasia
Product codes
GEX
Device Description
NOABLE LASER is a laser surgical instrument used during treatment where the laser 1450nm wavelength generated from the diode laser module. It can be used for incision, destruction and removal of skin tissue by illuminating a 1450 nm wavelength laser on the skin tissue.
Based on state-of-the-art diode laser technology, the system offers many advantages, including the combination of the effective wavelengths, excellent pulse characteristics, and unique dynamic cooling device (DCD) and compact instrument. Laser is sent out through the diode laser module equipped inside the Main body to oscillate the laser and the user uses the touch LCD in the Main body and hand-piece to set the output parameters while controlling laser radiation through the foot switch and hand-piece switch. At this point, a coolant is sprayed from the end of the hand- piece to protect skin from the heat generated by the radiated laser, resulting in a reduction in skin irritation and pain.
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
Non-clinical tests were conducted to verify that the proposed device met all design specification as was substantially equivalent (SE) to the predicate device.
Biocompatibility Testing: Evaluation conducted in accordance with ISO 10993-1, ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (skin sensitization - Guinea pig maximization test), and ISO 10993-23:2021 (irritation - animal irritation test by skin exposure).
Electrical Safety and electromagnetic Compatibility (EMC): Compliance with IEC 60601-1: 2005+A2:2020, IEC 60601-1-2:2014+A1:2020, and IEC 60825-1:2014.
Particular Performance Testing: Compliance with IEC 60601-1: 2005+A2:2020 and IEC 60601-2-22:2019.
Software Verification and Validation Testing: Conducted following FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" for a "Moderate" level of concern.
Accuracy Testing: Verified energy output and laser radiation range against setting values.
The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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March 7, 2025
Daeju Meditech Engineering Co., Ltd. % Lee April Consultant Withus Group Inc 106 Superior Irvine, California 92620
Re: K242207
Trade/Device Name: Noable Laser 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: February 7, 2025 Received: February 7, 2025
Dear Lee April:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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,
Digitally signed by YAN FU -S
YAN FU-S Date: 2025.03.07 09:29:02
-05'00'
for Tanisha Hithe
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
3
Indications for Use
Submission Number (if known)
Device Name
NOABLE LASER
Indications for Use (Describe)
For use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue, Treatment of back acne Treatment of atrophic acne scars
Treatment of facial wrinkles
Treatment of mild to moderate acne vulgaris
Treatment of Sebaceous Hyperplasia
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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4
510(k) Summary
Submitter
DAEJU MEDITECH ENGINEERING CO., LTD. SEONGUN KIM #501-504, HausD Sejong Tower, 26, Seongsu-il-ro 10-gil, Seongdong-gu Seoul, Republic of Korea 04793 Email: globalsales@daejumedi.co.kr Phone: +82-2-2208-0905
Device Information
- · Trade Name: NOABLE LASER
- · Common Name: 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: 03/06/2025
Predicate Device
Primary Predicate K173676, A-fit manufactured by Hironic Co., Ltd. Reference K041242, CANDELA SMOOTHBEAM LASER SYSTEM manufactured by CANDELA CORP.
Indications for use
For use in dermatology: incision, ablation, and vaporization with hemostasis of soft tissue, Treatment of back acne Treatment of atrophic acne scars Treatment of facial wrinkles Treatment of mild to moderate acne vulgaris Treatment of Sebaceous Hyperplasia
Device Description
NOABLE LASER is a laser surgical instrument used during treatment where the laser 1450nm wavelength generated from the diode laser module. It can be used for incision, destruction and removal of skin tissue by illuminating a 1450 nm wavelength laser on the skin tissue.
Based on state-of-the-art diode laser technology, the system offers many advantages, including the combination of the effective wavelengths, excellent pulse characteristics, and unique dynamic cooling device (DCD) and compact instrument. Laser is sent out through the diode laser module equipped inside the Main body to oscillate the laser and the user uses the touch LCD in the Main body and hand-piece to set the output parameters while controlling laser radiation through the foot switch and hand-piece switch. At this point, a coolant is sprayed from the end of the hand- piece to protect skin from the heat generated by the radiated laser, resulting in a reduction in skin irritation and pain.
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 | REFERENCE DEVICE | Remark |
|---|---|---|---|---|
| NOABLE LASER | A-Fit | CANDELA SMOOTHBEAM | ||
| LASER SYSTEM | ||||
| K number | K242207 | K173676 | K041242 | |
| Product Code | GEX | GEX | GEX | Same |
| Regulation | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Indications for | ||||
| Use | For use in dermatology: incision, | |||
| excision, ablation, and | ||||
| vaporization with hemostasis of | ||||
| soft tissue, | ||||
| Treatment of back acne | ||||
| Treatment of atrophic acne scars | ||||
| Treatment of facial wrinkles | ||||
| Treatment of mild to moderate | ||||
| acne vulgaris | ||||
| Treatment of Sebaceous | ||||
| Hyperplasia | Main Hand Piece | |||
| For use in dermatology: incision, | ||||
| excision, ablation, and | ||||
| vaporization with hemostasis of | ||||
| soft tissue, | ||||
| Treatment of back acne | ||||
| Treatment of atrophic acne scars | ||||
| Treatment of facial wrinkles | ||||
| Treatment of mild to moderate | ||||
| acne vulgaris | ||||
| Treatment of Sebaceous | ||||
| Hyperplasia | ||||
| Radio Frequency Hand piece | ||||
| The RF Hand piece energy is | ||||
| intended to provide topical | ||||
| heating for the purpose of | ||||
| elevating tissue temperature for | ||||
| the treatment of selected medical | ||||
| conditions such as relief of pain, | ||||
| muscle spasms, and increase in | ||||
| local circulation. | The Candela Smoothbeam Laser | |||
| is indicated for the following | ||||
| uses: | ||||
| For use in dermatology: incision, | ||||
| excision, ablation, and | ||||
| vaporization with hemostasis of | ||||
| soft tissue, | ||||
| Treatment of back acne | ||||
| Treatment of atrophic acne scars | ||||
| Treatment of facial wrinkles | ||||
| Treatment of mild to moderate | ||||
| acne vulgaris | ||||
| Treatment of Sebaceous | ||||
| Hyperplasia | Same | |||
| Light source | Diode Laser | Diode Laser | Diode Laser | Same |
| Wavelength- | ||||
| Beam radiation | $1450nm | |||
| {+} 10%$ | $1450nm | |||
| {+} 10%$ | 1450nm | Same | ||
| Wavelength - | ||||
| Beam Pointing | $635nm | |||
| {+} 10%$ | $635nm | |||
| {+} 10%$ | Unknown | Same | ||
| ITEM | PROPOSED DEVICE | PREDICATE DEVICE | REFERENCE DEVICE | Remark |
| Intended for | Prescription Use | Prescription Use | Prescription Use | Same |
| Maximum laser | ||||
| output | 4 J/cm2 - 12 J/cm2 ± 20% | |||
| (STAMPING mode) | ||||
| 4 J/cm2 - 8 J/cm2 ± 20% | ||||
| (TONING mode) | 4 J/cm2 - 13 J/cm2 ± 20% | |||
| (Soft and Normal modes) | 8-25 J/cm2 | Similar | ||
| Maximum laser | ||||
| output – Beam | ||||
| pointing |