Who is the manufacturer of DEKA SMARTPERIO?

El.En Electronic Engineering Spa filed the 510(k) submission for DEKA SMARTPERIO (K203396).

What is the FDA product code for DEKA SMARTPERIO?

NVK. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for DEKA SMARTPERIO?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like DEKA SMARTPERIO?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DEKA SMARTPERIO

Q: What are the predicate devices for DEKA SMARTPERIO?

PerioLase Dental Laser (K030290).

K203396 · El.En Electronic Engineering Spa · NVK · Aug 23, 2021 · General, Plastic Surgery

Device Facts

Record ID	K203396
Device Name	DEKA SMARTPERIO
Applicant	El.En Electronic Engineering Spa
Product Code	NVK · General, Plastic Surgery
Decision Date	Aug 23, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The DEKA SmartPerio system is intended to perform the following types of intraoral procedures: soft tissue dental, general, oral 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 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 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 pulsed laser system for intraoral soft tissue procedures; delivers 1064 nm laser energy via optical fiber, handpiece, and tip; operated by dental professionals in clinical settings; laser activation controlled by footswitch; system includes AC/DC power supply, CPU controller, laser source, cooling system, and LCD touch screen interface; device performs ablation, incision, excision, vaporization, and coagulation of soft tissues; output enables precise tissue management, hemostasis, and periodontal debridement; clinical benefit includes improved periodontal indices and minimally invasive surgical access.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical bench testing, including electrical safety (AAMI/ANSI ES60601-1), electromagnetic compatibility (IEC 60601-1-2), and laser safety (IEC 60601-2-22, IEC 60825-1).

Technological Characteristics

Nd:YAG laser; 1064 nm wavelength; 0.2-6W average power; contact fiber-optic delivery system; 635 nm aiming beam; 115V AC power; CPU-controlled; LCD touch screen interface; footswitch activation; compliant 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, and cosmetic surgical procedures, including periodontal treatments, gingival surgery, and root canal adjuncts.

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

PerioLase Dental Laser (K030290)

Related Devices

K030290 — PERIOLASE ND:YAG DENTAL LASER SYSTEM · Millennium Dental Technologies, Inc. · Jul 26, 2004
K014272 — PERIOLASE ND:YAG DENTAL LASER SYSTEM · Millennium Dental Technologies, Inc. · Mar 27, 2002
K024204 — FOTONA FIDELIS PLUS ND:YAG LASER SYSTEM · Fotona D.D. · Jul 7, 2003
K972325 — PULSEMASTER 1000 ST DENTAL LASER SYSTEM · American Dental Technologies, Inc. · Sep 19, 1997
K083215 — INCISIVE FAMILY OF INPULSE ND:YAG LASERS · Incisive, LLC · Apr 8, 2009

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. August 23, 2021 El.En. Electronic Engineering Spa Paolo Peruzzi Regulatory Affairs Manager Via Baldanzese 17 Calenzano, FI 50041 Italy Re: K203396 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: August 2, 2021 Received: August 6, 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. 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 {1}------------------------------------------------ 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 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 (OS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) #### K203396 Device Name DEKA SMARTPERIO | Indications for Use (Describe) | The DEKA SmartPerio system is intended to perform the following types of intraoral procedures: soft tissue dental, general, oral 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 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 tooth mobility. Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium.) | |-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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. {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ ### 510(K) Summary #### DEKA SMARTPERIO #### Submitter: El.En. S.p.A. Via Baldanzese, 17 50041 Calenzano (FI), Italy ## Contact: Paolo Peruzzi Regulatory Affairs Manager & Official Correspondent Phone: +39.055.8826807 E-mail: p.peruzzi@elen.it ### Date Summary Prepared: August 2, 2021 ### Device Trade Name: DEKA SMARTPERIO ### Common Name: Nd:YAG Pulsed Laser #### Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology #### Product Code : GEX Classification Number: 21 CFR 878.4810 #### Equivalent Device: Millennium Dental Technologies, Inc : PerioLase Dental Laser (K030290) (Primary predicate) #### 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 DEKA Smartperio device consist s of: - An AC/DC power supply unit - CPU controller {5}------------------------------------------------ #### K203396 - LASER source - . Cooling system - . User interface with LCD touch screen - . Beam delivery system Laser activation is controlled by footswitch. Electrical specifications are: 115V ~ single phase, 50/60 Hz, Absorbed electric power1840 VA (max) #### Indications for Use: The DEKA SmartPerio system is intended to perform the following types of intraoral procedures: soft tissue dental, general, oral 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 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 {6}------------------------------------------------ ## 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 tooth mobility. Laser assisted new attachment procedure (cementum-mediated periodontal ligament newattachment to the root surface in the absence of long junctional epithelium.) ## Comparison with the predicate device: DEKA SMARTPERIO is substantially equivalent to the Millennium Dental Technologies, Inc PerioLase Dental Laser System (K030290): | | Proposed 510(k) Device | Primary Predicate Device | Comparison | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Trade Name | DEKA SMARTPERIO K203396 | Millennium Dental Technologies, Inc : PerioLase Dental Laser K030290 | | | Indications for use | Intraoral procedures: soft tissue dental, general, oral maxillofacial, and cosmetic surgery. 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 | Intraoral soft tissue dental, general, oral maxillo-facial and cosmetic surgery. Intended for ablating, incising, excising, vaporization and coagulation of soft tissues using a contact fiber optic delivery system. The device will be used in the following areas: general and cosmetic dentistry, otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, gynecology, urology, ophthalmology and pulmonary surgery. The following are the oropharyngeal indications for use: Abscess Incision and Drainage Apthous Ulcers Treatment Biopsies Excision and Incision Crown lengthening | Indications for use of proposed device are a sub set of indications for use of the predicate device. Proposed device is not intended for otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, gynecology, urology, ophthalmology and pulmonary surgery. | | 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 degree) caries | Selective ablation of enamel (first degree) caries | | | | Exposure of unerupted / partially erupted teeth | Exposure of unerupted / partially erupted teeth | | | | Implant recovery | Implant recovery | | | | Lesion (tumor) removal | Lesion (tumor) removal | | | | Leukoplakia | Leukoplakia | | | | Pulpotomy | Pulpotomy | | | | Pulpotomy as adjunct to root canal therapy | 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 tooth mobility. | 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 tooth mobility. | | | | Laser assisted new attachment procedure (cementum-mediated periodontal ligament new- attachment to the root surface in the absence of long junctional epithelium.) | Laser assisted new attachment procedure (cementum-mediated periodontal ligament new- attachment to the root surface in the absence of long junctional epithelium.) | | | {7}------------------------------------------------ {8}------------------------------------------------ | Product code | 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 | 0.2-6W | 0.2-6W | Identical | | Aiming Beam wavelength | 635 nm | 635 nm | Identical | | Power of Aiming beam | 3 mW | 5mW | Similar, difference in aiming beam power does not affect safety and effectiveness. | | Delivery system | optical fiber (cleared with K124003, K200234) guided to the target tissue with the aid of handpiece and tip (cleared with K952006) | optical fiber guided to the target tissue with the aid of handpiece and tip | Similar delivery system accessories. Subject device uses already FDA cleared accessories, while for predicate device they are included in the device FDA clearance. This difference does not affect safety and effectiveness. | | Power Requirements | 115Vac, 50/60 Hz, 16Amps | 110-120 VAC, 50/60 Hz, 8 Amps, Single phase; 200 - 240 VAC, 50 Hz, 4 Amps | Both devices had power requirements consistent with US standards. Difference in power input current does not affect safety and effectiveness. | | Weight | 38 Kg | 45 lbs. [20.4 Kgs]/38 lbs. [17.2 Kgs] | Difference in weight does not affect safety and effectiveness. | | Dimensions | 68x23x65cm | 11" (width) x 19" (depth) x 25" (height) | Difference in dimensions does not affect safety and effectiveness. | | Biocompatibility | Yes- the only parts that can get in contact with patient have already been cleared by FDA (K124003, K200234, K952006) | YES (predicate device cleared by FDA) | Subject device relies on biocompatibility of accessories already cleared by FDA; no data available from predicate device | {9}------------------------------------------------ ## Clinical Performance Data: None ## Non-Clinical Performance Data: The DEKA SMARTPERIO has been tested and found in compliance with following standards: . AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012, cl:2009/(R)2012 and a2:2010/(R)2012 – Medical Electrical Equipment – Part 1: general requirements for basic safety and essential performance. . IEC 60601-1-2 Ed. 4 - Medical electrical equipment - part 1-2: general requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbance – Requirements and tests. . IEC60601-2-22 Ed 3.1 Medical electrical equipment – Part 2-2: Particular requirements for the basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment. . IEC 60825-1 Ed. 3.0 – Safety of laser products – Part 1 : Equipment classification, and requirements. ## Conclusion: 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 the DEKA SMARTPERIO is as safe, as effective, and performs as well as the legally marketed predicate device. ### Additional Information: None.