ERISE Laser handpiece

K202258 · El.En Electronic Engineering Spa · GEX · Apr 26, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K202258
• Device Name: ERISE Laser handpiece
• Applicant: El.En Electronic Engineering Spa
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 26, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ERISE Laser Handpiece is indicated for use in soft tissue (skin and cutaneous tissue) such as, but not limited to: Dermatology and plastic Surgery: Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectas; Actinic chelitis; Keloids; Verrucae; Skin tags; Keratoses; Scar revision (including acne scars). With microbeam end piece it is indicated for Skin resurfacing.

Device Story

ERISE is a 2940 nm Erbium:YAG laser handpiece; connects to DEKA LUXEA console (K192539) for power and control. Components include connector, cord, plastic shell, laser cavity, mechanical shutter, optical guide, and interchangeable tips (2, 4, 9mm spots; 9mm microbeam array). Operated by physicians in clinical settings for dermatological and plastic surgery procedures. Device delivers laser radiation to soft tissue; energy/fluence parameters controlled via console. Clinical benefit includes tissue ablation/resurfacing for aesthetic and therapeutic skin conditions. Healthcare providers use output to perform precise tissue removal or resurfacing; clinical decision-making based on visual assessment of skin condition and desired treatment depth.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical performance data, including electrical safety (IEC 60601-2-22, IEC 60825-1) and electromagnetic compatibility (IEC 60601-1-2) testing, alongside software verification and validation.

Technological Characteristics

2940 nm Er:YAG laser handpiece; 3 J max energy; 95-121 J/cm2 max fluence; 0.3-1.5 ms pulse duration; 6 Hz max repetition rate. Features microlens array for microbeam creation (300-600 μm diameter, 65-70 dots, 12% coverage). Connects to DEKA LUXEA console. Complies with IEC 60601-2-22, IEC 60825-1, and IEC 60601-1-2.

Indications for Use

Indicated for soft tissue (skin/cutaneous) procedures including skin resurfacing, wrinkle treatment, epidermal nevi, telangiectasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, and scar revision (including acne scars) in dermatology and plastic surgery patients.

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

• Quanta System 2940 nm Er:YAG laser handpiece (K173002)

Reference Devices

• DEKA LUXEA platform (K192539)

Submission Summary (Full Text)

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April 26, 2021

ELEN. Electronic Engineering Spa Paolo Peruzzi Regulatory Affair Manager Via Baldanzese 17 Calenzano, FI 50041 Italy

Re: K202258

Trade/Device Name: ERISE Laser handpiece 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 17, 2021 Received: March 23, 2021

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 (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.

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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 and Part 809); 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 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). 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Purva Pandya 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) K202258

Device Name ERISE Laser Handpiece

Indications for Use (Describe)

ERISE Laser Handpiece is indicated for use in soft tissue (skin and cutaneous tissue) such as, but not limited to: Dermatology and plastic Surgery: Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectas; Actinic chelitis; Keloids; Verrucae; Skin tags; Keratoses; Scar revision (including acne scars). With microbeam end piece it is indicated for Skin resurfacing.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| <div> <span> </span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span> </span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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### 510(K) Summary

### ERISE Laser Handpiece

### Submitter:

El.En. S.p.A.

Via Baldanzese, 17

50041 Calenzano (FI), Italy

### Contact:

Paolo Peruzzi

Regulatory Affairs Manager & Official Correspondent

Phone: [phone]

E-mail: [e-mail]

### Date Summary Prepared:

April 15, 2021

### Device Trade Name:

ERISE Laser handpiece

### Common Name:

2940 nm Er:YAG laser handpiece

### Classification:

Class II

### Classification Name:

Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology

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# Product Code :

GEX

## Classification Number:

21 CFR 878.4810

## Predicate Device:

- K173002 – Quanta System 2940 nm Er:YAG laser handpiece
## Device Description:

ERISE is an Erbium:YAG laser handpiece delivering laser radiation at 2940nm.

It is intended to be used with DEKA LUXEA platform, cleared by FDA with K192539.

The Erise laser handpiece includes:

- . A connector to connect to the console
- A cord where electrical cables and hydraulic tubes pass in
- A plastic shell
- . A Laser cavity
- . A mechanical shutter
- . An optical guide
- . An ending tip which provides different spot sizes (diameter 2, 4, 9mm), including microbeam output (diameter 9mm)

The 2940 nm Erbium:YAG laser handpiece is controlled by the DEKA LUXEA console which it is connected to, through the connector.

## Indications for Use:

ERISE Laser Handpiece is indicated for use in soft tissue (skin and cutaneous tissue) such as, but not limited to: Dermatology and plastic Surgery: Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Anal tags; Keratoses; Scar revision (including acne scars).

With microbeam end piece it is indicated for Skin resurfacing.

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# Technological Characteristics Comparison:

ERISE laser handpiece is as safe, as effective, and performs as well as the legally marketed predicate device Quanta System 2940 nm Er:YAG laser handpiece (K173002):

| | Proposed 510(k) Device | Predicate Device |
|------------------------------------|------------------------------------------------------------|------------------------------------------------------------|
| | | K173002 |
| Device Trade Name | ERISE laser handpiece | Quanta System 2940 nm Er:YAG laser<br>handpiece |
| Product code | GEX | GEX |
| Laser Wavelength | 2940 nm | 2940 nm |
| MAX Energy | 3 J | 3 J |
| | Up to 95 J/cm2 (non microbeam mode); | Up to 95 J/cm2 (non microbeam mode); |
| MAX Fluence | Up to 121 J/cm2 (with stacking pulses -<br>microbeam mode) | Up to 121 J/cm2 (with stacking pulses -<br>microbeam mode) |
| Handpiece Spot | Ø 2, 4, 9mm | Ø 2, 4, 9mm |
| Sizes | Ø 9mm dots array | Ø 9mm dots array |
| Pulse Duration | 0.3 to 1.5 ms | 0.3 to 1.5 ms |
| Pulse Repetition Rate | Up to 6 Hz | Up to 6 Hz |
| Diameter of the microbeams | 300- 600 μm | 300- 600 μm |
| Creation of microbeams | By microlenses array | By microlenses array |
| Number of dots | 65-70 | 65-70 |
| MAX Energy per Microbeam | 180 mJ (stacking mode) | 180 mJ (stacking mode) |
| Coverage of skin in microbeam mode | 12% | 12% |

## Clinical Performance Data:

None

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## Non-Clinical Performance Data:

The following performance data are provided in support of the substantial equivalence determination, for the ERISE laser handpiece used in conjunction with DEKA LUXEA platform.

### Safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the DEKA LUXEA platform.

The system complies with the IEC 60601-2-22, IEC 60825-1 standards for safety and the IEC 60601-1-2 standard for EMC.

## Software Verification and Validation Testing

Software of DEKA LUXEA platform successfully underwent verification and validation testing including the use of ERISE Handpiece.

Software documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

## Conclusions:

Based on the comparison of indications for use and the technological characteristics, and on the outcome of non-clinical performance data provided , we can conclude that ERISE Laser handpiece is as safe, as effective, and performs as well as the legally marketed predicate device.

## Additional Information:

None