(245 days)
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.
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.
Here's a breakdown of the requested information based on the provided FDA 510(k) summary for the EpilME device:
This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not present a detailed study proving the device meets specific acceptance criteria through clinical trials in the way you might expect for a new performance claim. Instead, it relies on comparison to a legally marketed predicate and adherence to recognized standards.
Here's an attempt to answer your questions based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for clinical performance in a quantifiable manner as you might see in a clinical study. Instead, it demonstrates substantial equivalence to a predicate device based on comparable intended use, indications for use, and technical specifications. The "performance" is implied by meeting recognized standards and having similar technical characteristics to the predicate.
| Acceptance Criteria (Implied by equivalence to predicate & standards) | Reported Device Performance (EpilME) |
|---|---|
| Safety and Effectiveness for Indications for Use: | EpilME has the same Indications for Use as the LightSheer Desire (K170179) predicate device (see below). |
| - Treatment of benign vascular lesions | Indicated |
| - Treatment of pseudofolliculitis barbae (PFB) | Indicated |
| - Hair removal, permanent hair reduction* | Indicated |
| - Treatment of benign pigmented lesions | Indicated |
| - Suitable for all skin types (Fitzpatrick I-VI), including tanned skin | Intended for use on all skin types (Fitzpatrick I-VI), including tanned skin. |
| - General Requirements for basic safety and essential performance (IEC 60601-1) | Test performed for IEC 60601-1:2005, AMD1:2012 |
| - Electromagnetic compatibility (IEC 60601-1-2) | Test performed for IEC 60601-1-2:2014 |
| - Particular requirements for safety and performance of laser equipment (IEC 60601-2-22) | Test performed for IEC 60601-2-22:2007 |
| - Biological Evaluation of Medical Devices (ISO 10993-1) | Test performed for ISO 10993-1:2018 |
| Technical Specifications comparable to predicate for effective treatment: | |
| - Output wavelength | 808 nm +/- 20nm |
| - Pulse Duration | 50 ms |
| - Spot Size | 10mm x 21 mm |
| - Max Energy | Up to 80J |
| - Rep Rate | Up to 12 Hz |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical "test set" with a specific sample size and data provenance (e.g., country of origin, retrospective/prospective). The submission relies on demonstrating technical equivalence to a predicate device and adherence to recognized performance standards (e.g., IEC, ISO). This indicates that the primary "testing" for this 510(k) involves engineering bench testing and a comparison of specifications, not a clinical study on a patient cohort for the EpilME itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As described above, there is no clinical "test set" or ground truth established by experts in this 510(k) summary for the EpilME device's performance. The ground truth for the predicate device's efficacy would have been established during its original clearance/approval process.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no described clinical "test set" with expert adjudication.
5. 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
Not applicable. The EpilME is a laser device, not an AI-assisted diagnostic or interpretative tool. Therefore, an MRMC study related to human reader improvement with AI is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The EpilME is a physical laser device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the EpilME device itself, the "ground truth" for its safety and functional performance is based on engineering standards (IEC, ISO) and the demonstrated technical equivalence to the predicate device, which has established clinical efficacy for its stated indications. There is no new clinical ground truth generated for the EpilME beyond these comparisons and standards adherence.
8. The sample size for the training set
Not applicable. This device is a laser system, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
In summary:
This 510(k) submission for the EpilME laser system primarily demonstrates substantial equivalence to a previously cleared predicate device (LightSheer Desire Laser System K170179) and compliance with recognized safety and performance standards. It does not present a de novo clinical study with specific acceptance criteria, a test set, expert adjudication, or MRMC/AI performance data for the EpilME itself. The "proof" the device meets acceptance criteria is derived from its similar technical specifications and intended uses to a device already deemed safe and effective by the FDA, and its adherence to relevant electrical and biological safety standards.
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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 America8480 Honeycutt RoadRaleigh, NC 27615 |
| Contact Person: | Joy Willard |
| Contact Information: | 984-777-5296joy@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 ingeneral and plastic surgery and in dermatology |
| Product Codes: | GEX |
| Legally Marketed Predicate Device: | LightSheer Desire Laser SystemK170179 |
| 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 andapplicator. The laser console provides a graphicaluser interface and software for control of the system,the needed electronics to control and power theaccessories, handpiece connection port and coolingsystem. |
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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 | |||
| Indicationfor Use | Laser EpilME with EpilME Applicator is indicated foruse in surgical and aesthetic applications in themedical specialties of general and plastic surgery, anddermatology.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 vascularlesions, including angiomas,hemangiomas, telangiectasia andother benign vascularlesions and legveins Treatment of pseudofolliculitisbarbae (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 monthsafter the completion of a treatment regime. | The LightSheer Desire System is indicated for usein surgical, aesthetic, and cosmetic applications inthe medical specialties of general and plasticsurgery, and dermatology.The LightSheer Desire System is intended for useon all skintypes (Fitzpatrick skin types I - VI),including tanned skin.The LightSheer Desire System with LightSheer ET/XC805nm Laser Handpieces are 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 measured at 6, 9, and 12 monthsafter 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 |
| Outputwavelength | 808 nm +/- 20nm | 790-830nm (805 nm nominal) |
| Pulse Duration | 50 ms | 5-400ms |
| Spot Size | 10mm x 21 mm | 9mm x 9mm12mm 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.
§ 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.