(245 days)
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No
The document describes a laser system with a graphical user interface and software for control, but there is no mention of AI or ML capabilities, image processing, or data sets typically associated with AI/ML training or testing. The performance studies focus on electrical and biological safety standards.
Yes
The intended uses, such as treatment of benign vascular lesions, pseudofolliculitis barbae, and benign pigmented lesions, are therapeutic applications. Additionally, the device is described as being used in "surgical, cosmetic, therapeutic and diagnostic laser equipment".
No
The provided text describes the device's indications for use in treatment (e.g., hair removal, treatment of lesions), not for diagnosis. There is no mention of the device analyzing or interpreting patient data for diagnostic purposes.
No
The device description explicitly states it is an "electro-optical device consisting of a laser console and applicator," which are hardware components. While it includes software for control, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for surgical and aesthetic applications directly on the patient's body (treatment of vascular lesions, hair removal, treatment of pigmented lesions). IVDs are used to examine specimens taken from the body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description details an electro-optical device with a laser console and applicator, designed for direct application to the skin. This is consistent with a therapeutic or aesthetic device, not a diagnostic one that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, using reagents, or providing diagnostic information based on laboratory tests.
The device is a laser system intended for therapeutic and aesthetic procedures performed directly on the patient.
N/A
Intended Use / Indications for Use
Laser EpilME with EpilME Applicator is indicated for use in surgical and aesthetic applications in the medical specialties of general and plastic surgery, and dermatology.
The EpilME is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.
The EpilMe with EpilME Applicator is intended for:
- Treatment of benign vascular lesions, including angiomas, telangiectasia and other benign vascular lesions and leg veins
- Treatment of pseudofolliculitis barbae (PFB)
- Hair removal, permanent hair reduction *
- Treatment of benign 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 regime.
Product codes
GEX
Device Description
The Laser EpilME with EpilME applicator is an electro-optical device consisting of a laser console and applicator. The laser console provides a graphical user interface and software for control of the system, the needed electronics to control and power the accessories, handpiece connection port and cooling system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 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 logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 2, 2022
Neauvia North America Joy Willard Director of Quality, Regulatory, and Clinical Affairs 8480 Honeycutt Road Raleigh, North Carolina 27615
Re: K213261
Trade/Device Name: EpilME 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: May 4, 2022 Received: May 5, 2022
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.
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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); 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 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-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) K213261
Device Name EpilME
Indications for Use (Describe)
Laser EpilME with EpilME applictor is indicated for use in surgical and aesthetic applications in the medical specialties of general and plastic surgery, and dermatology.
The EpilME is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.
The EpilMe with EpilME Applicator is intended for:
- · Treatment of benign vascular lesions, including angiomas, telangiectasia and other benign vascular lesions and leg veins
- · Treatment of pseudofolliculitis barbae (PFB)
- · Hair removal, permanent hair reduction *
- · Treatment of benign 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 regime.
| 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 EpilME is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.
| 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: | June 2, 2022 |
| Device Trade Name: | EpilME Laser |
| Common Name: | Powered laser surgical instrument |
| Regulation Name: | 21 CFR 878.4810, Laser Surgical Instrument for use in |
| general and plastic surgery and in dermatology | |
| Product Codes: | GEX |
| Legally Marketed Predicate Device: | LightSheer Desire Laser System |
| K170179 | |
| Regulatory Class: | Class II Prescription Use |
| Description of the EpilME Laser: | The Laser EpilME with EpilME applicator is an electro- |
| optical device consisting of a laser console and | |
| applicator. The laser console provides a graphical | |
| user interface and software for control of the system, | |
| the needed electronics to control and power the | |
| accessories, handpiece connection port and cooling | |
| system. |
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Intended use of EpilME Laser: Laser EpilME with EpilME Applicator is indicated for use in surgical and aesthetic applications in the medical specialties of general and plastic surgery, and dermatology. The EpilME is intended for use on all skintypes (Fitzpatrick skin types I – VI), including tanned skin. The EpilMe with EpilME Applicator is intended for: o Treatment of benign vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign vascularlesions and leg veins ● Treatment of pseudofolliculitis barbae (PFB) ● Hair removal, permanent hair reduction* ● Treatment of benign pigmented lesions *Permanent hair reduction is defined as the longterm, stable reduction in the number of hairs regrowing when measuredat 6, 9, and 12 months after the completion of a treatment regime. IEC 60601-1:2005, AMD1:2012 Test for Medical Performance Data: Electrical equipment was performed for General Requirements for basic safety and essential performance. IEC 60601-1-2:2014 Test for Medical Equipment for General Requirements for basic safety and essential performance: electromagnetic compatibility IEC 60601-2-22: 2007 Test for Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment ISO 10993-1:2018 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process
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| EpilMe Laser K213261 | LightSheer Desire K170179 | ||
|---|---|---|---|
| Indication for Use Comparison | |||
| Indication | |||
| for Use | Laser EpilME with EpilME Applicator is indicated for | ||
| use in surgical and aesthetic applications in the | |||
| medical specialties of general and plastic surgery, and | |||
| dermatology. |
The EpilME is intended for use on all skintypes
(Fitzpatrick skin types I – VI), including tanned skin.
The EpilMe with EpilME Applicator is intended for:
Treatment of benign vascular
lesions, including angiomas,
hemangiomas, telangiectasia and
other benign vascularlesions and leg
veins Treatment of pseudofolliculitis
barbae (PFB) Hair removal, permanent hair reduction* Treatment of benign pigmented lesions *Permanent hair reduction is defined as the long-
term, stable reduction in the number of hairs re-
growing when measuredat 6, 9, and 12 months
after the completion of a treatment regime. | The LightSheer Desire System is indicated for use
in surgical, aesthetic, and cosmetic applications in
the medical specialties of general and plastic
surgery, and dermatology.
The LightSheer Desire System is intended for use
on all skintypes (Fitzpatrick skin types I - VI),
including tanned skin.
The LightSheer Desire System with LightSheer ET/XC
805nm Laser Handpieces are intended for:
Treatment of benign vascular lesions,
including angiomas, hemangiomas,
telangiectasia and other benign vascular
lesions and leg veins Treatment of pseudofolliculitis barbae (PFB) Hair removal, permanent hair reduction* Treatment of benign 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 regime. | Same |
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| Technical Comparison | ||
|---|---|---|
| EpilME | LightSheer Desire K170179 | |
| Power supply | 220 - 240 VAC, 50/60Hz, max 2600 VA | 100-240 VAC, 15 A max. 50/60 Hz |
| Output | ||
| wavelength | 808 nm +/- 20nm | 790-830nm (805 nm nominal) |
| Pulse Duration | 50 ms | 5-400ms |
| Spot Size | 10mm x 21 mm | 9mm x 9mm |
| 12mm x 12mm | ||
| Max Energy | Up to 80J | Up to 81J |
| Rep Rate | up 12 Hz | 3 Hz |
Conclusion: The EpilMe's intended use, indications for use and technical y equivaltially equivalent to the predicate device. There are no new questions of safety raised.