(86 days)
Not Found
No
The device description and summary of performance studies focus solely on the light-based technology and its physical properties, with no mention of AI or ML algorithms for analysis, control, or other functions.
Yes
The NUNA LUX is intended for the use in treating full-face wrinkles, which is a therapeutic purpose.
No
The device is described as a light-based device intended for treating full-face wrinkles, not for diagnosing any condition.
No
The device description explicitly states it is a "light based device" and details hardware components like LEDs, optical lenses, and battery operation. It also mentions performance studies involving "lab bench testing" and "Electrical safety, EMC, Additional safety testing, Biocompatibility testing, Performance testing (Skin Temperature Testing, LED Wavelength And Power Density Testing)," all of which are related to hardware.
Based on the provided information, the NUNA LUX is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "treating full-face wrinkles." This is a therapeutic application, not a diagnostic one. IVD devices are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device uses light therapy to treat wrinkles. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any aspects related to collecting, processing, or analyzing biological specimens, which are fundamental to IVD devices.
Therefore, the NUNA LUX is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NUNA LUX is an Over-the-Counter (OTC) light based device intended for the use in treating full-face wrinkles.
Product codes (comma separated list FDA assigned to the subject device)
OHS
Device Description
The NUNA LUX is an Over-the-Counter (OTC) light based device intended for the use in treating full-face wrinkles. NUNA LUX is a battery-operated device that uses low power light spectrum at red and infrared, at wavelength of 808 ±5nm, 620 ±5nm emitting optical power in a uniform distribution. The NUNA LUX incorporates a near-infrared LED light source within the optimum Therapeutic Optical Window at 808 nm, optimized for Low Level Light Therapy, and a red LED light source at 620 nm. An optical lens that diffuses the light to produce narrowband, divergent distribution across an 8 cm2 treatment area. The energy output of the 808 nm and 620 nm wavelengths is 62.5 mW/cm2 which produces a beneficial treatment for full-face wrinkles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Entire Face
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-the-Counter (OTC)
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)
Non-clinical Testing:
The NUNA LUX has been evaluated the safety and performance by lab bench testing and conforms to the following international consensus standards:
Electrical safety:
- ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)];
EMC: - IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment Part • 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests;
Additional safety testing: - IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION Medical electrical equipment -• Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical systems used in the home healthcare environment;
- IEC 62471 First edition 2006-07 Photobiological safety of lamps and lamp systems;
- . IEC 60825-1 Edition 2.0 2007-03 Safety of laser products - Part 1: Equipment classification, and requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]
Biocompatibility testing: - ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices Part 5: Tests for in • vitro cytotoxicity;
- ISO 10993-10 Fourth edition 2021-11 Biological evaluation of medical devices - Part 10: Tests for skin sensitization;
- ISO 10993-23 First edition 2021-01 Biological evaluation of medical devices - Part 23: Tests for irritation;
Performance testing: - Skin Temperature Testing •
- LED Wavelength And Power Density Testing
Key results: The conclusion drawn from the non-clinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device K210823.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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, with the letters "FDA" in a blue box. To the right of the blue box is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 1, 2024
Premier North America Inc. Doris Dong General Manager 3301 SW 42nd St Fort Lauderdale, Florida 33312-6828
Re: K233862
Trade/Device Name: Nuna Lux (nunl528) 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 1, 2023 Received: December 6, 2023
Dear Doris Dong:
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 (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/cdrb/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.
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 (QS) 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 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).
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 L. Hithe Tanisha L. s 2024.03.01 Hithe -S 15:06:45 -05'00'
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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
NUNA LUX (NUNL528)
Indications for Use (Describe)
The NUNA LUX is an Over-the-Counter (OTC) light based device intended for the use in treating full-face 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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4
510(k) Summary [As required by 21 CFR 807.92]
| 1. Submission Information | |
|---|---|
| 510(k) Number: | K233862 |
| Date: | December 1, 2023 |
| Type of 510(k) Submission: | Traditional 510(k) |
| Basis for 510(k) Submission: | New device |
| Owner: | Premier North America Inc. |
| 3301 SW 42ND ST., FORT LAUDERDALE, FL 33312-6828, USA | |
| Tel: +1-855-360-0650 | |
| Email: customerservice@premierna.com | |
| Web: www.premierdeadsea-usa.com | |
| Contact: | Doris Dong |
| [Consultant, from Shanghai CV Technology Co., Ltd.] | |
| Add: Room 602, No. 19 Dongbao Road, Songjiang Area, Shanghai, 201613 China | |
| E-mail: doris.d@ceve.org.cn | |
| Tel: 86 21-31261348 / Fax: 86 21-57712250 |
2. Device Description
| Proprietary Name: | NUNA LUX |
|---|---|
| Model: | NUNL528 |
| Classification Name: | Light Based Over The Counter Wrinkle Reduction (OHS) |
| Regulation Number: | 21 CFR 878.4810 |
| Product Code: | OHS |
| Device Class: | II |
| Review Panel: | General & Plastic Surgery |
| Device Description: | The NUNA LUX is an Over-the-Counter (OTC) light based device intended |
| for the use in treating full-face wrinkles. NUNA LUX is a battery-operated | |
| device that uses low power light spectrum at red and infrared, at wavelength | |
| of 808 ±5nm, 620 ±5nm emitting optical power in a uniform distribution. | |
| The NUNA LUX incorporates a near-infrared LED light source within the | |
| optimum Therapeutic Optical Window at 808 nm, optimized for Low Level | |
| Light Therapy, and a red LED light source at 620 nm. An optical lens that | |
| diffuses the light to produce narrowband, divergent distribution across an 8 | |
| cm2 treatment area. The energy output of the 808 nm and 620 nm | |
| wavelengths is 62.5 mW/cm2 which produces a beneficial treatment for | |
| full-face wrinkles. | |
| Indications for use: | The NUNA LUX is an Over-the-Counter (OTC) light based device intended |
| for the use in treating full-face wrinkles. |
3. Predicate Device Identification
| Predicate 510(k) Number: | K210823 |
|---|---|
| Marketing clearance date: | 03/18/2022 |
| Product name: | LYMA Laser |
| Manufacturer: | LYMA Life Ltd |
5
4. Substantial Equivalence to Predicate device
| New Device | Predicate Device | Remark | |
|---|---|---|---|
| 510(k) Number | To be assigned | K210823 | -- |
| Proprietary Name | NUNA LUX | LYMA Laser | -- |
| Model | NUNL528 | Not publicly available | -- |
| Owner | Premier North America Inc. | LYMA Life Ltd. | -- |
| Product Code | OHS | OHS | Same |
| Classification | II | II | Same |
| Indications for use | The NUNA LUX is an | ||
| Over-the-Counter (OTC) light based | |||
| device intended for the use in | |||
| treating full-face wrinkles. | The LYMA Laser is an | ||
| Over-the-Counter (OTC) light based | |||
| device intended for the use in treating | |||
| full-face wrinkles. | Same | ||
| Type | Hand-held | Hand-held | Same |
| Materials | Rigid ABS and stainless steel | Rigid ABS and stainless steel | Same |
| Target Population | Individuals with full-face wrinkles. | Individuals with full-face wrinkles. | Same |
| Anatomical Sites | Entire Face | Entire Face | Same |
| Light source | Light emitting diode (LED) | Light emitting diode (LED) | Same |
| Light spectrum | |||
| region | Red and infrared | Red and infrared | Same |
| Wavelengths | $620 \pm 5nm$ , $808 \pm 5nm$ | $620 nm$ , $808 nm$ | Same |
| Waveform | Constant | Constant | Same |
| Visible light | |||
| LEDs | Yes | Yes | Same |
| Energy source | 6 pcs 620 nm LEDs +1 pcs 808 nm | ||
| LEDs (over 8 cm2) | 620 nm LEDs + 808 nm LEDs (over 8 | ||
| cm2) | Similar | ||
| Energy density | 62.5mW/cm2 | 62.5mW/cm2 | Same |
| Initial treatment | |||
| course | 3 minutes per treatment area,every | ||
| day for 8 weeks.After 8 weeks,use | |||
| for 3 minutes per treatment area,3 | |||
| times per week. | 3 minutes per treatment area,every day | ||
| for 8 weeks.After 8 weeks,use for 3 | |||
| minutes per treatment area,3 times per | |||
| week. | Same | ||
| Power supply | Lithium battery | Lithium battery | Same |
5. Non-clinical Testing
The NUNA LUX has been evaluated the safety and performance by lab bench testing and conforms to the following international consensus standards:
Electrical safety:
-
ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)];
EMC: -
IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment Part ● 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests;
Additional safety testing: -
IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION Medical electrical equipment -● Part 1-11: General requirements for basic safety and essential performance - Collateral Standard:
6
Requirements for medical electrical equipment and medical systems used in the home healthcare environment;
- IEC 62471 First edition 2006-07 Photobiological safety of lamps and lamp systems;
- . IEC 60825-1 Edition 2.0 2007-03 Safety of laser products - Part 1: Equipment classification, and requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]
Biocompatibility testing:
- ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices Part 5: Tests for in ● vitro cytotoxicity;
- ISO 10993-10 Fourth edition 2021-11 Biological evaluation of medical devices - Part 10: Tests for skin sensitization;
- ISO 10993-23 First edition 2021-01 Biological evaluation of medical devices - Part 23: Tests for irritation;
Performance testing:
- Skin Temperature Testing ●
- LED Wavelength And Power Density Testing
6. Conclusions
The conclusion drawn from the non-clinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device K210823.