Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

Device Description

The NIRVANA is a diode laser device indicated for hair removal and permanent hair reduction. The device is provided with two different handpieces that deliver the laser energy to the patient. The NIRVANA electrical specifications are: 100-115V~, 50/60Hz, 1600VA.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called "Nirvana," a diode laser indicated for hair removal and permanent hair reduction. It details the device's characteristics, its comparison to predicate devices, and non-clinical performance data.

However, the document does not contain information about acceptance criteria or a study that proves the device meets those criteria in a clinical performance context. Specifically, there is no mention of:

Clinical performance data: The document explicitly states "Clinical Performance Data: None."
Acceptance criteria for device performance: There is no table or description of specific metrics (e.g., accuracy, sensitivity, specificity, reduction percentage) that the device must achieve to be considered effective or safe, especially in terms of hair reduction.
Study design for clinical evaluation: No information on sample size, data provenance, ground truth establishment, expert involvement, or statistical analysis for clinical effectiveness is provided.
AI/Algorithm performance metrics: This device is a laser hair removal system, not an AI-driven diagnostic or assistive device. Therefore, metrics like MRMC studies, standalone algorithm performance, or human-in-the-loop improvement with AI assistance are not applicable.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on:

Intended Use/Indications: The Nirvana device's indications for use are a subset of or identical to the predicate and reference devices.
Technical Specifications: Comparison of wavelengths, spot sizes, fluence, pulse duration, and power to predicate devices.
Non-Clinical Performance Data: Electrical safety, EMC, and software validation testing to relevant standards.

Therefore, I cannot fulfill your request for: "A table of acceptance criteria and the reported device performance" (clinical performance), "Sample sized used for the test set and the data provenance," "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," "Standalone performance," "Type of ground truth," "Sample size for the training set," and "How the ground truth for the training set was established" because this information is not present in the provided 510(k) summary.

The manufacturer has demonstrated substantial equivalence through non-clinical means and comparison to legally marketed predicate devices, rather than through a new clinical performance study. This is a common pathway for 510(k) clearances when a device is sufficiently similar to existing ones.

Summary

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April 10, 2024

El.En. S.p.A. Paolo Peruzzi Regulatory Affairs Manager Via Baldanzese 17 Calenzano, FL 50141 Italy

Re: K234057

Trade/Device Name: Nirvana 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: March 14, 2024 Received: March 14, 2024

Dear Paolo Peruzzi:

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/ofdocs/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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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 (OS) 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.

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 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).

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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-devices/deviceadvice-comprehensive-regulatory-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.

Tanisha Digitally signed by Tanisha L L. Hithe - Hithe -s Date: 2024.04.10 2 1 15:21:02 -04'0

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

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Indications for Use

510(k) Number (if known) K234057

Device Name Nirvana

Indications for Use (Describe)

The Nirvana device is indicated for hair removal and permanent hair reduction.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing 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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510(k) Summary

K234057

NIRVANA

Submitter:

El.En. S.p.A. Via Baldanzese, 17 50041 Calenzano (FI), Italy

Contact:

Paolo Peruzzi Regulatory Affairs Manager & Official Correspondent Phone: +39.055.8826807 E-mail: p.peruzzi@elen.it

Date Summary Prepared:

March 22nd, 2024

Device Trade Name:

NIRVANA

Common Name:

Medical Laser

Regulation Number:

21 CFR 878.4810

Regulation Name:

Laser Surgical Instrument for use in General and Plastic and in Dermatology

Regulatory Class:

Class II

Product Code:

GEX

Predicate Devices:

Primary predicate:
Reference predicate:

DEKA LUXEA (K192539) ASCLEPION MeDioStar (K192483)

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Device Description:

Indications for Use:

The Nirvana device is indicated for hair removal and permanent hair reduction.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

Comparison with The Predicate Device:

The NIRVANA is as safe, as effective, and performs as well as the legally marketed predicate devices (K192539 and K192483):

DeviceTrade Name	Proposed DeviceNirvana	Predicate DeviceDEKA LUXEAVIVID LASER handpiece(K192539)	Reference DeviceASCLEPIONMeDioStar(K192483)	Comment
Indicationsfor Use	Indicated for hair removaland permanent hairreduction.Permanent hair reductionis defined as the long-term, stable reduction inthe number of hairsregrowing when measuredat 6, 9, and 12 monthsafter the completion of atreatment regime.	Indicated for thetreatment of benignvascular lesions, benignpigmented lesions, hairremoval and permanenthair reduction.Permanent hair reductionis defined as the long-term, stable reduction inthe number of hairsregrowing when measuredat 6, 9, and 12 monthsafter the completion of atreatment regime	Intended for surgical,aesthetic and cosmeticapplications in the medicalspecialties of general andplastic surgery anddermatology.Intended for the treatmentof benign vascular lesions.Intended for the treatmentof benign pigmentedlesions.Intended for hair removal,permanent hair reductiondefined as reduced hairgrowth with or withoutmaintenance whenmeasured at 6, 9 and 12months.	Subset ofpredicatedevice andreferencedevice
Regulationnumber	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	Identical
ProductCode	GEX	GEX	GEX	Identical
Device Type	Diode Laser	Diode laser	Diode Laser	Identical
DeviceTrade Name	Proposed DeviceNirvana	Predicate DeviceDEKA LUXEAVIVID LASER handpiece(K192539)	Reference DeviceASCLEPIONMeDioStar(K192483)	Comment
Wavelength	809 ± 6 nm	808 ± 10 nm	760± 10 nm808± 10 nm940 ± 10 nm	Same aspredicatedevice, subsetof referencedevice
HandpieceSpot Size	12x24 mm12x12mm	10x12 mm	Spot size at 808± 10 nm:10 x 10 mm15 x 10 mm30 x 10 mm31.6 x 31.6 mm	Larger thanpredicatedevice, withinthe ranges ofreferencedevice
Max Fluence	40 J/cm²	40 J/cm²	Max fluence at 808± 10nm:60 J/cm²	Identical topredicatedevice, withinthe range ofreferencedevice
PulseDuration	Up to 200 ms	Up to 200 ms	Up to 400 ms	Identical topredicatedevice, withinthe range ofreferencedevice
Max outputpeak power	1800W	900W	4200W	Higher thanpredicatedevice, withinthe range ofreferencedevice
Max outputaveragepower	174W	81W	250W	Higher thanpredicatedevice, withinthe range ofreferencedevice
PulseRepetitionRate (Hz)	Single shot to 10 Hz	Single shot to 10 Hz	Up to 20Hz	Identical topredicatedevice, withinthe range ofreferencedevice

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Clinical Performance Data:

None

Non-Clinical Performance Data:

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the NIRVANA device, according to the following standards:

. ANSI AAMI ES60601-1Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.

. IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.

. IEC 60601-2-22: Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

. IEC 60825-1: Safety of laser products - Part 1: Equipment classification and requirements.

Software Validation and Verification Testing

Software verification and validation testing were conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions".

Conclusion:

On the basis of the comparison with the predicate device and on the non-clinical performance data, we can conclude that NIRVANA is as safe, as effective, and performs as well as the legally marketed predicate devices (K192539 and K192483).

Additional Information:

None.

Regulation Number and Section

§ 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.