(188 days)
Not Found
No
The description focuses on the laser technology and its parameters (wavelength, power, spacing, energy) and does not mention any AI or ML components for image processing, data analysis, or treatment planning.
Yes
Explanation: The device is intended for dermatological procedures requiring coagulation of soft tissue, skin resurfacing, and treatment of benign pigmented lesions and facial wrinkles/fine lines, which are all therapeutic interventions.
No
The device is described as a non-ablative diode laser intended for therapeutic dermatological procedures such as skin resurfacing, treatment of benign pigmented lesions, and facial wrinkles and fine lines. Its function involves delivering laser energy to tissue, which is a treatment, not a diagnostic, activity.
No
The device description explicitly states it is a "non-ablative diode laser" with a specific wavelength and power, indicating it is a hardware device that emits laser energy.
Based on the provided information, the LaserMe device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the LaserMe is for dermatological procedures requiring coagulation of soft tissue and skin resurfacing, and for treating benign pigmented lesions and facial wrinkles/fine lines. These are all procedures performed directly on the patient's body.
- Device Description: The device description details a laser that works by applying energy to the skin. This is a therapeutic or cosmetic device, not a diagnostic one.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The LaserMe does not perform any such analysis of specimens.
Therefore, the LaserMe is a medical device used for therapeutic and cosmetic purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LaserMe is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures. The LaserMe is further indicated for treatment of benign pigmented lesions, such as, but not limited to lentigines (age spots), solar lentigos (sun spots), melasma, dyschromia, and for treatment of facial wrinkles and fine lines.
Product codes
GEX
Device Description
LaserME is a non-ablative diode laser. The device is equipped with a diode laser with a wavelength of 1470 nm and a maximum power of 2W, intended for nonablative skin resurfacing. The device works by punctuating the skin (epidermis) with several micro laser beams. The points are evenly spaced with adjustable spacing from 1mm to 4mm. The energy delivered to a single point is regulated from 5mJ to 50mJ.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue and skin
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
The thermal effects of the LaserME and tissue healing process were evaluated in 18 healthy volunteers. The study was conducted by exposing human subjects to a single laser treatment followed by histology analysis performed immediately, 3 and 10 days post treatment. The study results show that the LaserMe behaved as intended.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 17, 2023
Neauvia North America Joy Willard Director of Quality, Regulatory, and Clinical Affairs 8480 Honevcutt Road Raleigh, North Carolina 27615
Re: K230077
Trade/Device Name: LaserME 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: June 15, 2023 Received: June 16, 2023
Dear Joy Willard:
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
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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 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,
Image /page/1/Picture/5 description: The image shows the name "Jianting Wang -S" in a large, clear font. The text is horizontally oriented and appears to be the primary focus of the image. The background is plain, ensuring the text is easily readable.
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230077
Device Name LaserME
Indications for Use (Describe)
The LaserMe is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures. The LaserMe is further indicated for treatment of benign pigmented lesions, such as, but not limited to lentigines (age spots), solar lentigos (sun spots), melasma, dyschromia, and for treatment of facial wrinkles and fine lines.
| 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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This 510(K) Summary of safety and effectiveness for the LaserME is submitted in accordance with the requirements of 21 CFR 807.92.
Applicant: Neauvia North America Address: Neauvia North America 8480 Honeycutt Road Raleigh, NC 27615 Contact Person: Joy Willard Contact Information: 984-777-5296 joy@neauvia-us.com Preparation Date: January 23, 2022 Device Trade Name: LaserME Powered laser surgical instrument Common Name: Regulation Name: 21 CFR 878.4810, Laser Surgical Instrument for use in general and plastic surgery and in dermatology Product Codes: GEX Emerge Fractional Laser K111840 Legally Marketed Predicate Device: Regulatory Class: Class II Prescription Use Description of the LaserME Laser LaserME is a non-ablative diode laser. The device is equipped with a diode laser with a wavelength of 1470 System: nm and a maximum power of 2W, intended for nonablative skin resurfacing. The device works by punctuating the skin (epidermis) with several micro laser beams. The points are evenly spaced with adjustable spacing from 1mm to 4mm. The energy delivered to a single point is regulated from 5mJ to 50mJ.
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Intended use of LaserME
The LaserMe is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures. The LaserMe is further indicated for treatment of benign pigmented lesions, such as, but not limited to lentigines (age spots), solar lentigos (sun spots), melasma, dyschromia, and for treatment of facial wrinkles and fine lines.
| Specifications | LaserME | Emerge Fractional Laser K111840 |
|---|---|---|
| Laser type | Diode | Diode |
| Power Supply | 112-240 VAC, 50/60Hz | 110-240 VAC, 50/60Hz |
| Output wavelength | 1470 +/- 20nm | 1410nm |
| Pulse Time | 30ms | Max 20ms |
| Applicator Window | 12 x 12mm | 12mm x 8mm |
| Energy | 5mJ-50mJ | 10mJ to 30mJ |
| No. of microbeams | Up to 70 | Up to 70 |
| Repetition | ||
| Frequency | Up to 18Hz | Up to 30Hz |
| Weight | 4 Kg | Handpiece: 250 g |
| Base: 3 kg | ||
| Dimensions | 156 x 335 x 421 mm | Unknown |
| Indications for use | The LaserMe is intended for use | |
| in dermatological procedures | ||
| requiring coagulation of soft | ||
| tissue and skin resurfacing | ||
| procedures. The LaserMe is | ||
| further indicated for treatment | ||
| of benign pigmented lesions, | ||
| such as, but not limited to | ||
| lentigines (age spots), solar | ||
| lentigos (sun spots), melasma, | ||
| dyschromia, and for treatment of | ||
| facial wrinkles and fine lines. | The Emerge Fractional Laser is | |
| intended for use in dermatological | ||
| procedures requiring coagulation | ||
| of soft tissue and skin resurfacing | ||
| procedures. The Emerge Fractional | ||
| Laser is further indicated for | ||
| treatment of pigmented lesions, | ||
| such as, but not limited to lentigos | ||
| (age spots), solar lentigos (sun | ||
| spots), melasma, dyschromia, and | ||
| for treatment of facial wrinkles and | ||
| fine lines. | ||
| Non-clinical Testing: | The following performance data was provided in | |
| support of the substantial equivalence determination: | ||
| IEC 60601-1 Test for Medical Electrical equipment | ||
| was performed for General Requirements for basic | ||
| safety and essential performance. |
Comparison to the Predicate Device:
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| | IEC 60601-1-2 Test for Medical Equipment for
General Requirements for basic safety and essential
performance: electromagnetic compatibility |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | IEC 60601-2-22 Test for Particular requirements for
basic safety and essential performance of surgical,
cosmetic, therapeutic and diagnostic laser equipment |
| | ISO 10993-1 Biological Evaluation of Medical
Devices - Part 1: Evaluation and Testing Within a Risk
Management Process |
| | Histological assessment in ex vivo tissue to
demonstrate that the extent of the damage induced due
to the worst-case pulse energy of the subject device is
comparable to the damage induced due to the worst-
case pulse energy of the predicate device. |
| Clinical Testing: | The thermal effects of the LaserME and tissue healing
process were evaluated in 18 healthy volunteers. The
study was conducted by exposing human subjects to a
single laser treatment followed by histology analysis
performed immediately, 3 and 10 days post treatment.
The study results show that the LaserMe behaved as
intended. |
Conclusion: Based on the comparison and analysis above, the proposed subject device LaserME is determined to be Substantially Equivalent (SE) to the predicate device.