(245 days)
Not Found
No
The provided text does not mention any AI or ML components in the device description, intended use, or performance studies.
Yes
The device is indicated for the treatment of periorbital wrinkles, which constitutes a therapeutic effect.
No
The NIRA Beauty Skin Laser is indicated for the treatment of periorbital wrinkles, and its description and performance studies focus on its therapeutic effect (wrinkle reduction) rather than diagnosis.
No
The device description explicitly states it is a "hand-held reusable OTC non-fractional diode laser device" and lists physical components like a hand piece, battery charger, and USB cable, indicating it is a hardware device with potential software control, not a software-only device.
Based on the provided information, the NIRA Beauty Skin Laser is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
- NIRA Beauty Skin Laser Function: The description clearly states that the NIRA Beauty Skin Laser is a "hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength" used for the "treatment of periorbital wrinkles." This is a direct treatment applied to the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is for treating wrinkles, not for diagnosing or monitoring a condition based on a biological sample.
- Device Description: The description focuses on the physical device and its components, not on reagents, assays, or sample handling.
- Performance Studies: The performance studies described are clinical studies on human subjects, assessing the effectiveness and safety of the device when applied to the skin, not studies evaluating the performance of a diagnostic test on biological samples.
Therefore, the NIRA Beauty Skin Laser falls under the category of a therapeutic or cosmetic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NIRA Beauty Skincare Laser is indicated for the treatment of periorbital wrinkles.
Product codes
OHS
Device Description
The NIRA Beauty Skincare Laser is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA Laser consists of a hand piece, wall-plug battery charger, and USB cable. The hand piece fits in the hand and the laser light comes out of the tip. There is a single micro-USB connector interface that provides two functions: battery charging and USB communication (for 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
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)
Human – Self Selection and Usability:
A Self-selection study successfully assessed whether or not naive laypersons 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:
A clinical study was conducted. The clinical study for periorbital wrinkles was a 76 subject, open-label comparison to baseline effectiveness, and safety study.
Efficacy: Periorbital treatment met its predefined clinical and statistical endpoint with a median reduction of 1 unit in the FWS. An improvement of at least one score was seen in 69% of subjects on overall facial wrinkles assessment. 68% of users who achieved wrinkle reduction of 1 full scale unit maintained some wrinkle improvement for at least 3 months after users stopped using NIRA.
Safety: No unanticipated or severe adverse events were reported. Adverse events reported included skin warmth and stinging, dryness, and temporary skin color changes where skin became darker in color. These were not unexpected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
An improvement of at least one score was seen in 69% of subjects on overall facial wrinkles assessment.
68% of users who achieved wrinkle reduction of 1 full scale unit maintained some wrinkle improvement for at least 3 months after users stopped using NIRA.
Predicate Device(s)
K090525 Palomar LOI System
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, layered on top of each other. The profiles are connected by flowing lines, creating a sense of unity and movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 12, 2017
Dermal Photonics Corporation Mr. David Bean CEO 5 Elm St. Suite 10 Danvers, Massachusetts 01923
Re: K163137
Trade/Device Name: Nira Beauty Skin Laser 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: June 8, 2017 Received: June 12, 2017
Dear Mr. Bean:
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. 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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Jennifer R. Stevenson -S3
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K163137
Device Name NIRA Beauty Skin Laser
| Indications for Use (Describe) | The NIRA Beauty Skin Laser 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)
- Dermal Photonics A) Submitted by: 5 Elm Street, Suite 10 Danvers, MA 01923
- Official Contact: David Bean CEO dbean@dermalphotonics.com (781) 451-1701
B) Classification Names: Light based Over the Counter Wrinkle Reduction
| Proprietary Name: | NIRA Beauty Skincare Laser |
|---|---|
| Device Class: | Class II |
| Regulations | 21 CFR 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology |
| Product Codes: | OHS |
| Classification panel: | General & Plastic Surgery |
| C) Primary Predicate: | K090525 Palomar LOI System |
| D) Date Prepared: | April 27, 2017 |
E) Device Description:
The NIRA Beauty Skincare Laser is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA Laser consists of a hand piece, wall-plug battery charger, and USB cable. The hand piece fits in the hand and the laser light comes out of the tip. There is a single micro-USB connector interface that provides two functions: battery charging and USB communication (for charging).
E) Intended Use/Indications For Use:
The NIRA Beauty Skincare Laser is indicated for the treatment of periorbital wrinkles.
F) Substantial Equivalence Comparison and Discussion
| | Dermal Photonics
NIRA Beauty Skincare Laser
K163137 | Palomar
LOI System
K090525 |
|-----------------|-----------------------------------------------------------|----------------------------------|
| Product
code | OHS | ONG |
4
| | Dermal Photonics
NIRA Beauty Skincare Laser
K163137 | Palomar
LOI System |
|------------------------|---------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| | | K090525 |
| Indications
for Use | The NIRA Laser is indicated for the
treatment of periorbital wrinkles. | The LOI System is an over-the-counter
device intended for treatment of
periorbital wrinkles. |
| OTC | Yes | Yes |
Similarities
The NIRA Laser has similar indications for use, is an OTC device and uses a similar wavelength as the predicate device.
The NIRA Laser has similar clinical efficacy three (3) months after users stopped using NIRA, similar to the Palomar LOI System.
Like the predicate device, the NIRA Laser meets all electrical, EMC, or Laser, and FCC testing requirements.
Differences
Differences between the NIRA Laser and the predicate devices include:
- Pulse/treatment duration ●
- Treatment schedules
Conclusion
Differences between the NIRA Laser and the predicate device do not raise different issues of safety or effectiveness. The NIRA Laser was demonstrated in a clinical study to be safe and effective and meet its indication for use. The NIRA Laser is substantially equivalent to the predicate devices.
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G) 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 all electrical, EMC, or Laser, and FCC testing 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 naive laypersons 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
A clinical study was conducted. The clinical study for periorbital wrinkles was a 76 subject, open-label comparison to baseline effectiveness, and safety study.
Efficacv
Periorbital treatment met its predefined clinical and statistical endpoint with a median reduction of 1 unit in the FWS. An improvement of at least one score was seen in 69% of subjects on overall facial wrinkles assessment.68% of users who achieved wrinkle reduction of 1 full scale unit maintained some wrinkle improvement for at least 3 months after users stopped using NIRA.
Safety
No unanticipated or severe adverse events were reported. Adverse events reported included skin warmth and stinging, dryness, and temporary skin color changes where skin became darker in color. These were not unexpected.
H) Consensus Standards
The NIRA Beauty Skincare Laser complies with the following standards:
- ETSI EN 300 440-2 v1.4.1 (2010-08): Electromagnetic compatibility and Radio spectrum . Matters (ERM); Short range devices; Radio equipment to be used in the 1 GHz to 40 GHz frequency range; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive
- ETSI EN 301 489-1 v1.9.2 (2011-09) Electromagnetic compatibility and Radio spectrum ● Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements
- ETSI EN 301 489-3 v1.6.1 (2002-08) Electromagnetic compatibility and Radio spectrum ● Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and
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services: Part 3: Specific conditions for Short-Range Devices (SRD) operating on frequencies between 9 kHz and 246 GHz
- IEC 60601-1-2:2007 (Third Edition) 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: 2010 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 60355-1: 2010 Household and similar electrical appliances - Safety - Part 1: General requirements
- IEC 60355-2-23:2008 Household and similar electrical appliances Safety Part 2-23: . Particular requirements for appliances for skin or hair care
- IEC 60825-1: 2007 Safety of laser products Part 1: Equipment classification and ● requirements
- . ASTM D4169-14 Standard Practice for Performance Testing of Shipping Containers and Systems
- IEC 62366 (First Edition) + A1:2014 Medical devices -- Part 1: Application of usability engineering to medical devices
- IEC 60601-1-6: 2010 (Third Edition) +A1;2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- AAMI ANSI HE75: 2009/(R) 2013 Human factors engineering Design of medical ● devices
Conclusion
The NIRA Laser is substantially equivalent to the predicate devices. Clinical data demonstrate that the NIRA Laser is safe and effective, and meets its indications for use.