(110 days)
No
The summary describes a standard diode laser device for hair removal and does not mention any AI/ML components or capabilities.
No.
The intended use of the device is hair removal and permanent hair reduction, which are considered cosmetic procedures, not therapeutic medical treatments for a disease or condition.
No
The device is indicated for hair removal and permanent hair reduction, which are therapeutic applications, not diagnostic ones. Diagnostics involve identifying diseases or conditions.
No
The device description explicitly states it is a "diode laser device" and is provided with "two different handpieces that deliver the laser energy to the patient," indicating it is a hardware device that uses laser technology for hair removal.
Based on the provided information, the Nirvana device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "hair removal and permanent hair reduction." This is a cosmetic or therapeutic procedure performed directly on the patient's body.
- Device Description: The device is described as a "diode laser device" that delivers energy to the patient via handpieces. This is consistent with a medical device used for external treatment.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVDs are devices used to perform tests on samples taken from the human body to provide information about a person's health. The Nirvana device does not fit this description.
N/A
Intended Use / 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.
Product codes
GEX
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.
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 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".
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.
0
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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
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 (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).
2
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
3
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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)
5
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.
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):
| Device
Trade Name | Proposed Device
Nirvana | Predicate Device
DEKA LUXEA
VIVID LASER handpiece
(K192539) | Reference Device
ASCLEPION
MeDioStar
(K192483) | Comment |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Indications
for Use | 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. | Indicated for the
treatment of benign
vascular lesions, benign
pigmented lesions, 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 | Intended for surgical,
aesthetic and cosmetic
applications in the medical
specialties of general and
plastic surgery and
dermatology.
Intended for the treatment
of benign vascular lesions.
Intended for the treatment
of benign pigmented
lesions.
Intended for hair removal,
permanent hair reduction
defined as reduced hair
growth with or without
maintenance when
measured at 6, 9 and 12
months. | Subset of
predicate
device and
reference
device |
| Regulation
number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Identical |
| Product
Code | GEX | GEX | GEX | Identical |
| Device Type | Diode Laser | Diode laser | Diode Laser | Identical |
| Device
Trade Name | Proposed Device
Nirvana | Predicate Device
DEKA LUXEA
VIVID LASER handpiece
(K192539) | Reference Device
ASCLEPION
MeDioStar
(K192483) | Comment |
| Wavelength | 809 ± 6 nm | 808 ± 10 nm | 760± 10 nm
808± 10 nm
940 ± 10 nm | Same as
predicate
device, subset
of reference
device |
| Handpiece
Spot Size | 12x24 mm
12x12mm | 10x12 mm | Spot size at 808± 10 nm:
10 x 10 mm
15 x 10 mm
30 x 10 mm
31.6 x 31.6 mm | Larger than
predicate
device, within
the ranges of
reference
device |
| Max Fluence | 40 J/cm² | 40 J/cm² | Max fluence at 808± 10
nm:
60 J/cm² | Identical to
predicate
device, within
the range of
reference
device |
| Pulse
Duration | Up to 200 ms | Up to 200 ms | Up to 400 ms | Identical to
predicate
device, within
the range of
reference
device |
| Max output
peak power | 1800W | 900W | 4200W | Higher than
predicate
device, within
the range of
reference
device |
| Max output
average
power | 174W | 81W | 250W | Higher than
predicate
device, within
the range of
reference
device |
| Pulse
Repetition
Rate (Hz) | Single shot to 10 Hz | Single shot to 10 Hz | Up to 20Hz | Identical to
predicate
device, within
the range of
reference
device |
6
7
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.