(155 days)
Not Found
No
The provided text does not mention AI, ML, or any related concepts like deep learning, neural networks, or image processing that would typically indicate the presence of AI/ML in a medical device. The description focuses on the laser technology and basic software documentation.
Yes
The device is indicated for the "treatment of periorbital wrinkles," which implies a therapeutic purpose.
No
The device is indicated for the "treatment of periorbital wrinkles," not for the diagnosis of a condition. It is a therapy device.
No
The device description explicitly states it is a "hand-held reusable OTC non-fractional diode laser device" and includes a "handheld piece and USB charging cable," indicating it is a physical hardware device. While it contains software, it is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "treatment of periorbital wrinkles." This is a therapeutic use, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a laser used for treatment. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: The description lacks any mention of analyzing samples, reagents, or any other components typically associated with IVD devices.
The NIRA Model 2 is a therapeutic device used for a cosmetic treatment.
N/A
Intended Use / Indications for Use
The NIRA Model 2 is indicated for the treatment of periorbital wrinkles.
Product codes
OHS
Device Description
The NIRA Model 2 is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA Laser consists of a handheld piece and USB charging cable. The handheld fits in the hand and the laser light comes out of the tip. There is a single USB C connector for battery charging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
periorbital (wrinkles)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use (21 CFR 801 Subpart C)
OTC home use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench: The NIRA Laser meets electrical safety, EMC, usability engineering, laser safety, and FCC regulations requirements. Software documentation was provided consistent with FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", May 11. 2005 and a Moderate Level of Concern.
Human - Self Selection and Usability: A Self-selection study successfully assessed whether or not lay person could correctly determine (self-select) if they are appropriate candidates for use of the NIRA device based solely on reading the box labeling. A Usability study successfully assessed that the NIRA Laser is usable by the device's intended users in a simulated use environment.
Human – Clinical: Safety and clinical efficacy of the predicate device was assessed in human clinical trial performed in 2016. Since the Model 2 has substantially equivalent intracutaneous temperature elevation for very similar time, no separate clinical trial was performed for the Model 2.
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
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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 8, 2023
Dermal Photonics Corp Felix Feldchtein Vice President 153 Andover St, Ste 111 Danvers, Massachusetts 01923
Re: K222685
Trade/Device Name: NIRA Model 2 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: OHS Dated: December 5, 2022 Received: December 6, 2022
Dear Felix Feldchtein:
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,
Jianting Wang -S
Jianting Wang Acting 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) K222685
Device Name NIRA Model 2
Indications for Use (Describe) The NIRA Model 2 is indicated for the treatment of periorbital wrinkles.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Traditional 510(k) Summary as required by 21 CFR 807.92(a)
| A) Submitted by: | Dermal Photonics
153 Andover St
Danvers, MA 01923 |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Official Contact: | David Bean
CEO and President |
| B) Classification Names:
Proprietary Name: | Light Based Over-The-Counter Wrinkle Reduction
NIRA Model 2 |
| Device Class: | Class II |
| Regulations | 21 CFR 878.4810 Laser surgical instrument for use in general and
plastic surgery and in dermatology |
| Product Code: | OHS |
| Classification panel: | General & Plastic Surgery |
| C) Predicate: | K163137 NIRA Beauty Skincare Laser |
| D) Date Prepared: | August 30, 2022 |
E) Device Description:
The NIRA Model 2 is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA Laser consists of a handheld piece and USB charging cable. The handheld fits in the hand and the laser light comes out of the tip. There is a single USB C connector for battery charging.
F) Intended Use/Indications For Use:
The NIRA Model 2 is indicated for the treatment of periorbital wrinkles.
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| Specifications | |||
|---|---|---|---|
| NIRA Model 2 | Predicate K163137 | ||
| NIRA Skin (Model 1) | Comparison | ||
| Spot size | 12.5 x 13.8 mm2 | 4x4 mm2 | Different |
| Light source | Non-fractional diode laser | Non-fractional diode laser | Same |
| Wavelength | 1450 ±20 nm | 1450 ±20 nm | Same |
| Pulse | 2.0-3.1 sec pulse train | 0.8 sec pulse train | Different |
| Laser max power | 2 W | 2 W | Same |
| Laser energy | |||
| density (fluence) | 2.1, 2.4, 2.7, 3.2 and 3.8 J/cm2 | 2.16, 2.32, 2.48, 2.66, 2.97 J/cm2 | Different |
| Laser cooling | Forced Convection w/ fan | Natural Convection | SE |
| Laser fire start | Contact sensor, auto-trigger | ||
| when all capacitive sensors | |||
| engaged on skin | Contact sensor+Trigger button | SE | |
| OTC home use | Yes | Yes | Same |
| Treatment | |||
| schedule | Once or twice per day | Once or twice per day | Same |
| Weight | 5 oz | 5 oz | Same |
| Size | 6.7 x 2.6 x 1.6 inches | 6.7 x 2.4 x 1.6 inches | SE |
| Electrical, EMC | |||
| requirements | Yes | Yes | Same |
| Laser, FCC | |||
| requirements | Yes | Yes | Same |
| Usability | |||
| requirements | Yes | Yes | Same |
G) Substantial Equivalence Comparison and Discussion
Similarities
The NIRA Model 2 has the same indications for use, is an OTC device and uses the same wavelength as the predicate device.
Like the predicate device, the NIRA Model 2 meets electrical safety, EMC, usability engineering, laser safety, and FCC regulations requirements.
Differences
Differences between the NIRA Model 2 and the predicate device include (see the table for details):
- Pulse duration
- Beam size ●
- Laser fire start ●
- Laser engine cooling
Despite the differences noted above both devices have very similar laser fluence (energy density) and intracutaneous temperature elevation and therefore produce very similar biological effect on the skin tissue.
Conclusion
Differences between the NIRA Model 2 and the predicate device do not raise issues of safety or effectiveness. The NIRA Model 2 is substantially equivalent to the predicate device.
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H) Performance Testing
No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act.
Bench
The NIRA Laser meets electrical safety, EMC, usability engineering, laser safety, and FCC regulations requirements.
Software documentation was provided consistent with FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", May 11. 2005 and a Moderate Level of Concern
Human - Self Selection and Usability
A Self-selection study successfully assessed whether or not lay person could correctly determine (self-select) if they are appropriate candidates for use of the NIRA device based solely on reading the box labeling.
A Usability study successfully assessed that the NIRA Laser is usable by the device's intended users in a simulated use environment.
Human – Clinical
Safety and clinical efficacy of the predicate device was assessed in human clinical trial performed in 2016. Since the Model 2 has substantially equivalent intracutaneous temperature elevation for very similar time, no separate clinical trial was performed for the Model 2.
I) Recognized Consensus Standards
The Dermal Photonics NIRA Model 2 complies with the following standards:
- IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for . basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- AAMI ANSI ES 60601-1:2005(R)2012 and A1:2012, C1:2009/(R)2012 and . A2:2010/(R)2012 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance
- . IEC 60601-1-11: 2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 60825-1: 2014 Safety of laser products - Part 1: Equipment classification and requirements
- o In lieu of compliance with 21 CFR 1040.10 and 21 CFR 1040.11 per FDA laser notice #56.
- IEC 62366:2015 Medical devices -- Part 1: Application of usability engineering to . medical devices
- . IEC 60601-1-6: 2010 +A1:2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
Conclusion
The NIRA Laser is substantially equivalent to the predicate devices.