DEKA SMARTPERIO

K213658 · El.En Electronic Engineering Spa · NVK · Mar 11, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K213658
• Device Name: DEKA SMARTPERIO
• Applicant: El.En Electronic Engineering Spa
• Product Code: NVK · General, Plastic Surgery
• Decision Date: Mar 11, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The DEKA SmartPerio system is intended to perform intraoral soft tissue dental, general, oral maxillofacial, and cosmetic surgery. The DEKA SmartPerio is intended for ablating, incising, vaporization and coagulation of soft tissues using a contact fiber-optic delivery system. The device is intended to be used in dentistry. The following are the oropharyngeal indications for use: Abscess Incision and Drainage Apthous Ulcers Treatment Biopsies Excision and Incision Crown lengthening Hemostatic assistance Fibroma Removal Frenectomy Frenotomy Gingival Incision and Excision Gingivectomy Gingivoplasty Operculectomy Oral Papillectomy Tissue retraction for Impression Vestibuloplasty. Selective ablation of enamel (first degree) caries Exposure of unerupted / partially erupted teeth Implant recovery Lesion (tumor) removal Leukoplakia Pulpotomy Pulpotomy as adjunct to root canal therapy Removal of filling material such as gutta percha or resin as adjunct treatment during root canal retreatment Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment level and tooth mobility. Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium.)

Device Story

Nd:YAG laser device for intraoral soft-tissue dental, oral maxillofacial, and cosmetic surgery. System delivers 1064 nm laser energy via optical fiber, handpiece, and tip to target tissue. Used in dental clinics by trained professionals. Laser energy enables ablation, incision, vaporization, and coagulation of soft tissues. Clinician guides fiber-optic delivery system to target site; output provides precise tissue interaction for surgical procedures. Benefits include improved clinical indices in periodontal pockets and efficient soft tissue management. Modification from predicate involves increasing average output power from 6W to 10W.

Clinical Evidence

Bench testing only. No clinical data provided. Compliance with ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1 standards demonstrated.

Technological Characteristics

Nd:YAG laser; 1064 nm wavelength; 0.2-10W average power; 20-300 mJ energy per pulse; 10-100 Hz pulse frequency; 100-650 µs pulse duration. Contact fiber-optic delivery system. 635 nm aiming beam (5 mW). Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1.

Indications for Use

Indicated for patients requiring intraoral soft tissue dental, general, oral maxillofacial, or cosmetic surgery. Procedures include abscess drainage, ulcer treatment, biopsies, crown lengthening, hemostasis, fibroma removal, frenectomy/frenotomy, gingival procedures, operculectomy, papillectomy, tissue retraction, vestibuloplasty, caries ablation, tooth exposure, implant recovery, lesion removal, leukoplakia treatment, pulpotomy, root canal adjuncts, sulcular debridement, and laser-assisted new attachment.

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

• DEKA SMARTPERIO (K203396)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name in a sans-serif font. The logo is simple and professional, conveying the agency's authority and mission.

March 11, 2022

El.En Electronic Engineering Spa Paolo Peruzzi Regulatory Affairs Manager Via Baldanzese 17 Calenzano. Florida 50041

# Re: K213658

Trade/Device Name: DEKA Smartperio 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: NVK, GEX Dated: February 7, 2022 Received: February 10, 2022

# 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.

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

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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 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,

For Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental 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)

K213658

Device Name DEKA SMARTPERIO

Indications for Use (Describe)

### surgery. The DEKA SmartPerio is intended for ablating, incising, vaporization and coagulation of soft tissues using a contact fiber-optic delivery system. The device is intended to be used in dentistry. The following are the oropharyngeal indications for use: Abscess Incision and Drainage Apthous Ulcers Treatment Biopsies Excision and Incision Crown lengthening

Hemostatic assistance

Fibroma Removal

Frenectomy

-
Frenotomy

Gingival Incision and Excision

Gingivectomy

Gingivoplasty

Operculectomy

Oral Papillectomy

Tissue retraction for Impression

Vestibuloplasty.

Selective ablation of enamel (first degree) caries

Exposure of unerupted / partially erupted teeth

Implant recovery

Lesion (tumor) removal

Leukoplakia

Pulpotomy

Pulpotomy as adjunct to root canal therapy

Removal of filling material such as gutta percha or resin as adjunct treatment during root canal retreatment Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment level and tooth mobility. Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium.)

The DEKA SmartPerio system is intended to perform intraoral soft tissue dental, general, oral maxillofacial, and cosmetic

Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

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### K213658

### 510(K) Summary

#### DEKA SMARTPERIO – Special 510(k)

#### 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:

January 3, 2022

#### Device Trade Name:

DEKA SMARTPERIO

#### Common Name:

Laser, dental, soft tissue

#### Classification Name:

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

#### Product Code:

NVK, GEX

#### Regulatory Class:

Class II

#### Classification Number:

21 CFR 878.4810

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### Predicate Device:

DEKA SMARTPERIO (K203396)

### Device Description:

The DEKA SmartPerio is a Nd:YAG laser device for soft-tissues intraoral treatments. The DEKA SmartPerio system delivers laser through an optical fiber that is guided to the target tissue with the aid of an handpiece and a tip.

The modification to the device consists in the increasing of the average output power from 6W to 10W.

The intended use of the modified device, as described in the labelling, has not changed as a result of the modifications.

### Indications for Use:

The DEKA SmartPerio system is intended to perform intraoral soft tissue dental, gral maxillofacial, and cosmetic surgery. The DEKA SmartPerio is intended for ablating, incising, excising, vaporization and coagulation of soft tissues using a contact fiber-optic delivery system.

The device is intended to be used in dentistry.

The following are the oropharyngeal indications for use:

Abscess Incision and Drainage

Apthous Ulcers Treatment

Biopsies Excision and Incision

Crown lengthening

Hemostatic assistance

Fibroma Removal

Frenectomy

Frenotomy

Gingival Incision and Excision

Gingivectomy

Gingivoplasty

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Operculectomy Oral Papillectomy Tissue retraction for Impression Vestibuloplasty. Selective ablation of enamel (first degree) caries Exposure of unerupted / partially erupted teeth Implant recovery Lesion (tumor) removal Leukoplakia Pulpotomy Pulpotomy as adjunct to root canal therapy

Removal of filling material such as gutta percha or resin as adjunct treatment during root canal retreatment Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival bleeding index, probe depth, attachment level and tooth mobility tooth mobility.

Laser assisted new attachment procedure (cementum-mediated periodontal ligament newattachment to the root surface in the absence of long junctional epithelium.)

# Substantial equivalence discussion:

The modified DEKA SMARTPERIO is substantially equivalent to the DEKA SMARTPERIO device, cleared by FDA with K203396:

| | Proposed 510(k) Device | Predicate Device | Comparison |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | DEKA SMARTPERIO | DEKA SMARTPERIO | |
| Device Trade Name | | K203396 | |
| Indications for use | The DEKA SmartPerio system is intended to perform intraoral soft tissue dental, general, oral maxillofacial, and cosmetic surgery. The DEKA SmartPerio is intended for ablating, incising, excising, | The DEKA SmartPerio system is intended to perform intraoral soft tissue dental, general, oral maxillofacial, and cosmetic surgery. The DEKA SmartPerio is intended for ablating, incising, excising, | Identical |

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| vaporization and coagulation of soft | vaporization and coagulation of soft |
|--------------------------------------|--------------------------------------|
| tissues using a contact fiber-optic | tissues using a contact fiber-optic |
| delivery system. | delivery system. |
| The device is intended to be used in | The device is intended to be used in |
| dentistry. | dentistry. |
| The following are the oropharyngeal | The following are the oropharyngeal |
| indications for use: | indications for use: |
| Abscess Incision and Drainage | Abscess Incision and Drainage |
| Apthous Ulcers Treatment | Apthous Ulcers Treatment |
| Biopsies Excision and Incision | Biopsies Excision and Incision |
| Crown lengthening | Crown lengthening |
| Hemostatic assistance | Hemostatic assistance |
| Fibroma Removal | Fibroma Removal |
| Frenectomy | Frenectomy |
| Frenotomy | Frenotomy |
| Gingival Incision and Excision | Gingival Incision and Excision |
| Gingivectomy | Gingivectomy |
| Gingivoplasty | Gingivoplasty |
| Operculectomy | Operculectomy |
| Oral Papillectomy | Oral Papillectomy |
| Tissue retraction for Impression | Tissue retraction for Impression |
| Vestibuloplasty. | Vestibuloplasty. |
| Selective ablation of enamel (first | Selective ablation of enamel (first |
| degree) caries | degree) caries |
| Exposure of unerupted / partially | Exposure of unerupted / partially |
| erupted teeth | erupted teeth |
| Implant recovery | Implant recovery |
| Lesion (tumor) removal | Lesion (tumor) removal |
| Leukoplakia | Leukoplakia |
| Pulpotomy | Pulpotomy |
| Pulpotomy as adjunct to root canal | Pulpotomy as adjunct to root canal |
| therapy | therapy |

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| | Removal of filling material such as<br>gutta percha or resin as adjunct<br>treatment during root canal<br>retreatment Sulcular debridement<br>(removal of diseased or inflamed soft<br>tissue in the periodontal pocket) to<br>improve clinical indices including<br>gingival index, gingival bleeding index,<br>probe depth, attachment level and<br>tooth mobility tooth mobility.<br><br>Laser assisted new attachment<br>procedure (cementum-mediated<br>periodontal ligament new-attachment<br>to the root surface in the absence of<br>long junctional epithelium.) | Removal of filling material such as<br>gutta percha or resin as adjunct<br>treatment during root canal<br>retreatment Sulcular debridement<br>(removal of diseased or inflamed soft<br>tissue in the periodontal pocket) to<br>improve clinical indices including<br>gingival index, gingival bleeding index,<br>probe depth, attachment level and<br>tooth mobility tooth mobility.<br><br>Laser assisted new attachment<br>procedure (cementum-mediated<br>periodontal ligament new-attachment<br>to the root surface in the absence of<br>long junctional epithelium.) | |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Product code | NVK, GEX | GEX | Identical |
| Laser Wavelength | 1064 nm | 1064 nm | Identical |
| Energy per Pulse | 20-300 mJ | 20-300 mJ | Identical |
| Pulses per Second | 10-100 Hz | 10-100 Hz | Identical |
| Pulse duration | 100-650 µs | 100-650 µs | Identical |
| Average Power | 0.2-10W | 0.2-6W | The<br>modification<br>does not<br>adversely<br>affect safety<br>and<br>effectiveness |
| Aiming Beam<br>wavelength | 635 nm | 635 nm | Identical |
| Power of Aiming<br>beam | 5 mW | 5mW | Identical |

# Performance data:

# Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the modified DEKA SMARTPERIO device, according to the following standards:

- ANSI AAMI ES60601-1Medical electrical equipment Part 1: General requirements for basic safety and essential performance.

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- . IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests.
### Additional non-clinical testing conducted

Additional tests were conducted on the modified DEKA SMARTPERIO, according to the following standards:

- IEC 60601-2-22: Medical electrical equipment Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC 60825-1: Safety of laser products Part 1: Equipment classification and requirements.

### Conclusion:

Based on the comparison of indications for use and the technological characteristics, we can conclude that the modified DEKA SMARTPERIO is as safe, as effective, and performs as well as the unmodified legally marketed predicate device (K203396).