NUNA LUX (NUNL528)

K233862 · Premier North America, Inc. · OHS · Mar 1, 2024 · General, Plastic Surgery

Device Facts

• Record ID: K233862
• Device Name: NUNA LUX (NUNL528)
• Applicant: Premier North America, Inc.
• Product Code: OHS · General, Plastic Surgery
• Decision Date: Mar 1, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NUNA LUX is an Over-the-Counter (OTC) light based device intended for the use in treating full-face wrinkles.

Device Story

NUNA LUX is a battery-operated, handheld, OTC light-based device for treating full-face wrinkles. It utilizes red (620 ±5nm) and infrared (808 ±5nm) LED light sources to deliver energy at 62.5 mW/cm2 over an 8 cm2 treatment area. An optical lens diffuses light to produce a narrowband, divergent distribution. The device is intended for patient self-use at home. Treatment involves 3-minute sessions per area, daily for 8 weeks, followed by 3 times per week. The device provides low-level light therapy to improve the appearance of wrinkles.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included electrical safety (ANSI AAMI ES60601-1), EMC (IEC 60601-1-2), home healthcare environment safety (IEC 60601-1-11), photobiological safety (IEC 62471), laser safety (IEC 60825-1), biocompatibility (ISO 10993-5, -10, -23), skin temperature testing, and LED wavelength/power density verification.

Technological Characteristics

Handheld, battery-operated device. Materials: Rigid ABS and stainless steel. Light source: 6x 620nm LEDs, 1x 808nm LED. Energy density: 62.5 mW/cm2. Wavelengths: 620 ±5nm, 808 ±5nm. Standards: ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62471, IEC 60825-1, ISO 10993-5/10/23.

Indications for Use

Indicated for individuals with full-face wrinkles for OTC treatment.

Regulatory Classification

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.

Predicate Devices

• LYMA Laser (K210823)

Submission Summary (Full Text)

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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.

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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 (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).

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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 ([e-mail]) or phone [phone] 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

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# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K233862

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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# 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: [phone] |
| | Email: [e-mail] |
| | 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: [e-mail] |
| | Tel: [phone] / Fax: [phone] |

### 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<br>for the use in treating full-face wrinkles. NUNA LUX is a battery-operated<br>device that uses low power light spectrum at red and infrared, at wavelength<br>of 808 ±5nm, 620 ±5nm emitting optical power in a uniform distribution.<br>The NUNA LUX incorporates a near-infrared LED light source within the<br>optimum Therapeutic Optical Window at 808 nm, optimized for Low Level<br>Light Therapy, and a red LED light source at 620 nm. An optical lens that<br>diffuses the light to produce narrowband, divergent distribution across an 8<br>cm2 treatment area. The energy output of the 808 nm and 620 nm<br>wavelengths is 62.5 mW/cm2 which produces a beneficial treatment for<br>full-face wrinkles. |
| Indications for use: | The NUNA LUX is an Over-the-Counter (OTC) light based device intended<br>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 |

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### 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<br>Over-the-Counter (OTC) light based<br>device intended for the use in<br>treating full-face wrinkles. | The LYMA Laser is an<br>Over-the-Counter (OTC) light based<br>device intended for the use in treating<br>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<br>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<br>LEDs | Yes | Yes | Same |
| Energy source | 6 pcs 620 nm LEDs +1 pcs 808 nm<br>LEDs (over 8 cm2) | 620 nm LEDs + 808 nm LEDs (over 8<br>cm2) | Similar |
| Energy density | 62.5mW/cm2 | 62.5mW/cm2 | Same |
| Initial treatment<br>course | 3 minutes per treatment area,every<br>day for 8 weeks.After 8 weeks,use<br>for 3 minutes per treatment area,3<br>times per week. | 3 minutes per treatment area,every day<br>for 8 weeks.After 8 weeks,use for 3<br>minutes per treatment area,3 times per<br>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:

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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.