← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K222221 # DEKA HELIX (K222221) _El.En Electronic Engineering Spa · GEX · Jan 4, 2023 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K222221 ## Device Facts - **Applicant:** El.En Electronic Engineering Spa - **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md) - **Decision Date:** Jan 4, 2023 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use The Helix Laser System with its accessories is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery). ## Device Story The DEKA HELIX is a laser surgical system for dermatology and plastic surgery. It utilizes two laser sources (10600 nm CO2 and 1570 nm fiber laser) to perform soft tissue ablation, vaporization, excision, and coagulation. The system includes a console with an optical bench, high-voltage power supply, cooling system, and an articulated arm for delivery. Operators interact with the device via an LCD touch-screen control panel to set parameters and monitor system status. The device uses a dual-axis scanner for fractional applications. It is intended for use by trained clinicians in a clinical setting. The output is laser energy delivered to the patient's skin to achieve therapeutic effects like resurfacing or lesion removal. The device is controlled by a footswitch and includes safety interlocks. It is designed to provide precise tissue interaction, benefiting patients by enabling controlled surgical and aesthetic procedures. ## Clinical Evidence No clinical data. Bench testing only, including electrical safety (ANSI AAMI ES60601-1), electromagnetic compatibility (IEC 60601-1-2), and performance testing per IEC 60601-2-22 and IEC 60825-1. ## Technological Characteristics Class II laser surgical instrument. Dual-wavelength: 10600 nm (RF-excited CO2) and 1570 nm (fiber laser). Features: articulated arm, dual-axis scanner, cooled tips, LCD touch-screen interface. Electrical: 100-230V, 50/60 Hz. Cooling: closed-loop heat exchanger. Standards: ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1. ## Regulatory 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 - Alma Hybrid Laser System ([K203441](/device/K203441.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font. January 4, 2023 El.En Electronic Engineering Spa Paolo Peruzzi Regulatory Affairs Manager Via Baldanzese 17 Calenzano, Firenze 50041 Italy Re: K222221 Trade/Device Name: Deka Helix 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, ONG Dated: December 2, 2022 Received: December 5, 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. {1}------------------------------------------------ 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 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 medical devices and radiation-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. # Jianting Wang -S Jianting Wang Acting 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K222221 Device Name DEKA HELIX #### Indications for Use (Describe) The Helix Laser System with its accessories is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery). #### CO2 Handpieces The Helix CO2 handpieces with wavelength of 10600 nm are indicated for use for the particular indications as follows: #### Dermatology & Plastic Surgery The ablation, vaporization, excision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of: - * laser skin resurfacing - * laser derm-abrasion - * laser burn debridement. Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: warts, acne scars, nevi epidermal, syringoma. Vaporization/coagulation of warts. Scanning unit The Helix Scanning unit, with wavelength of 10600 nm is indicated for: ·Laser skin resurfacing (ablation and/or vaporization) of soft tissue The Helix Scanning unit, with wavelength of 1570 nm, is indicated for: · Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue The Helix Scanning unit, with wavelengths of 10600 nm & 1570mm is indicated for laser skin resurfacing (ablation and/or vaporization) of soft tissue. | 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 #### K222221 ## DEKA HELIX #### 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: July 20, 2022 ## Device Trade Name: DEKA HELIX #### Common Name: Powered Laser Surgical Instrument #### Classification Name: Powered laser surgical Instrument Powered laser surgical instrument with microbeam\fractional output #### Product Code: GEX ONG {5}------------------------------------------------ ## Regulatory Class: Class II #### Classification Number: 21 CFR 878.4810 ## Predicate Device: The Alma Hybrid Laser System (K203441) #### Device Description: The Helix system consists of: • Laser system console (containing the optical bench assembly and laser, the microcontroller control electronics and system software, the high voltage power supply, the laser cooling system, the compressed air-purge system, and the service panel) • LCD control panel with touch-screen technology: the LCD display provides information on the status and settings of the Helix system with touch-screen technology provided to input commands into the system. - Two wavelengths CO2 and 1570 nm - Articulated arm - Footswitch - Delivery devices (CO₂ non-fractional applicators, Scanner CO₂/1570nm fractional applicator) Electrical specifications are: 100-230V ~ single phase, 50/60 Hz, Absorbed electric power 1500 VA (max) #### Indications for Use: The Helix Laser System with its accessories is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery). #### CO₂ handpieces {6}------------------------------------------------ The Helix CO handpieces, with wavelength of 10600nm, are indicated for use for the particular indications as follows: Dermatology and Plastic Surgery The ablation, vaporization, excision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of: laser skin resurfacing laser derm-abrasion laser burn debridement. Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: warts, acne scars, nevi epidermal, syringoma. Vaporization/coagulation of warts. #### Scanning unit The Helix Scanning unit, with wavelength of 10600 nm is indicated for: Laser skin resurfacing (ablation and/or vaporization) of soft tissue The Helix Scanning unit, with wavelength of 1570 nm, is indicated for: Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue The Helix Scanning unit, with wavelengths of 10600nm & 1570nm is indicated for laser skin resurfacing (ablation and/or vaporization) of soft tissue. ## Comparison with The Predicate Device: The DEKA HELIX is substantially equivalent to Alma Hybrid Laser System (K203441) | Device Trade Name | Proposed Device
DEKA HELIX | Predicate Device
The Alma Hybrid Laser
System (K203441) | Comment | |--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------| | Indications for Use | The Helix Laser System
with its accessories is
intended for use in
surgical applications
requiring the ablation,
vaporization, excision,
incision, and coagulation
of soft tissue in medical
specialties including:
aesthetic surgery
(dermatology and plastic | The Alma Hybrid Laser
System, Delivery Devices,
Applicators and
Accessories are intended
for use in surgical
applications requiring the
ablation, vaporization,
excision, incision, and
coagulation of soft tissue
in medical specialties
including: aesthetic | Identical | | Device Trade Name | Proposed Device
DEKA HELIX | Predicate Device
The Alma Hybrid Laser
System (K203441) | Comment | | | surgery).

CO2 handpieces

The Helix CO2 handpieces,
with wavelength of
10600nm, are indicated
for use for the particular | surgery (dermatology and
plastic surgery).

Hy-Light CO2

The Alma Hybrid CO2 non-
fractional applicator, with
wavelength of 10600 nm is | | | | indications as follows:

Dermatology and Plastic
Surgery

The ablation, vaporization,
excision, incision, and | cleared for use for the
particular indications as
follows:

Dermatology & Plastic | | | | coagulation of soft tissue
in dermatology and plastic
surgery in the
performance of:

*laser skin resurfacing

*laser derm-abrasion | Surgery

The ablation, vaporization,
excision, incision, and
coagulation of soft tissue
in dermatology and plastic
surgery in the
performance of: | | | | *laser burn debridement.

Laser skin resurfacing
(ablation and/or
vaporization) of soft tissue | * laser skin resurfacing

* laser derm-abrasion

* laser burn debridement. | | | | for the reduction,
removal, and/or
treatment of: warts, acne
scars, nevi epidermal,
syringoma.

Vaporization/coagulation
of warts. | Laser skin resurfacing
(ablation and/or
vaporization) of soft tissue
for the reduction,
removal, and/or
treatment of: warts, acne
scars, nevi epidermal,
syringoma.

Vaporization/coagulation | | | Device Trade Name | Proposed Device | Predicate Device | Comment | | | DEKA HELIX | The Alma Hybrid Laser System (K203441) | | | | Scanning unit | of warts. | | | | The Helix Scanning unit, with wavelength of 10600 nm is indicated for:
Laser skin resurfacing (ablation and/or vaporization) of soft tissue | Pixel
The Alma Hybrid Pixel CO2 fractional applicator, with wavelength of 10600 nm is indicated for: The ablation, vaporization and coagulation of soft tissues in dermatology and plastic surgery in the performance of skin resurfacing. | | | | The Helix Scanning unit, with wavelength of 1570 nm, is indicated for:
Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue | | | | | The Helix Scanning unit, with wavelengths of 10600nm & 1570nm is indicated for laser skin resurfacing (ablation and/or vaporization) of soft tissue. | ProScan
The Alma Hybrid ProScan CO2 fractional applicator, with wavelength of 10600 nm is indicated for:
•Laser skin resurfacing (ablation and/or vaporization) of soft tissue
The Alma Hybrid ProScan 1570nm fractional applicator, with wavelength of 1570 nm, is indicated for:
• Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue | | | | | | | | Device Trade Name | Proposed Device
DEKA HELIX | Predicate Device
The Alma Hybrid Laser
System (K203441) | Comment | | | | CO2 &1570nm fractional
applicator, with
wavelengths of 10600 nm
&
1570nm is indicated for
laser skin resurfacing
(ablation and/or
vaporization) of soft
tissue. | | | Regulation number | 21 CFR 878.4810 Laser
surgical instrument for
use in general and
plastic surgery and in
dermatology | 21 CFR 878.4810 Laser
surgical instrument for
use in general and
plastic surgery and in
dermatology | Identical | | Product Code | GEX
ONG | GEX
ONG | Identical | | System Control | Fully computerized | Fully computerized | Identical | | Emission Control | Footswitch
Interlock | Footswitch
Interlock | Identical | | User Interface | Touch-screen display
Emergency button
Key switch | Touch-screen display
Emergency button
Key switch | Identical | | Cooling System | Closed loop, heat
exchanger | Closed loop, heat
exchanger | Identical | | Emission indicator | Visual
Audible | Visual
Audible | Identical | | Electrical
Requirements | 100-230 V, 16A 50/60 Hz,
single phase | 120 VAC, 11 A, 50/60 Hz,
single phase
220/230 VAC, 6 A, 50/60
Hz, single phase | Differences do not
affect safety and
effectiveness. | | | | | | | Device Trade Name | Proposed Device
DEKA HELIX | Predicate Device
The Alma Hybrid Laser
System (K203441) | Comment | | Physical
Dimensions and
Weight | 62 cm x 63 cm x 138/202
cm (erected)
~ 70 Kg | 465mm x 533 mm x
1345/1973 mm (erected)
~ 86 Kg | Differences do not
affect safety and
effectiveness. | | Laser Type | RF-excited CO2 laser, Class
4
Fiber Laser, Class 4 | RF-excited CO2 laser, Class
4
Fiber Laser, Class 4 | Identical | | CO2 Handpieces | | | | | Wavelength | 10600 nm | 10600 nm | Identical | | Pilot beam | 635nm, 4mW | 650 nm, 3mW | Differences do not
affect safety and
effectiveness. | | Spot size (mm) | 0.125 – 2.0 mm | 0.15 – 3.0 at 50 mm
working distance
0.25- 3.1 (Dia.) at 200 mm
working distance | Differences do not
affect safety and
effectiveness | | Pulse Duration | 10 - 900ms | 1-1000 ms | Differences do not
affect safety and
effectiveness. | | Pulse Repetition
Frequency | 0.2 — 200 Hz | 1 — 100 Hz | Differences do not
affect safety and
effectiveness. | | Min output energy | 5 mJ | 5 mJ | Identical | | Output Power | 70W | 30W, 70W | Differences do not
affect safety and
effectiveness. | | Scanning unit | | | | | Wavelenght | 10600 nm and/or 1570
nm | 10600 nm and/or 1570 nm | Identical | | Pilot beam | 635nm, 4mW | 650 nm, 3mW | Differences do not
affect safety and
effectiveness. | | Device Trade Name | Proposed Device
DEKA HELIX | Predicate Device
The Alma Hybrid Laser
System (K203441) | Comment | | Scanner | Dual axis scanner | Dual axis scanner | Identical | | Tip | Cooled | Cooled | Identical | | Spot size @ 10600
nm | 0.374mm | 0.35 mm@ 100 mm
distance | Differences do not
affect safety and
effectiveness. | | Scan size @ 1570
nm | 20x20 mm | Up to 30 mm diameter | Differences do not
affect safety and
effectiveness. | | Spot size @ 1570
nm | 0.75mm | 0.75 mm | Identical | | Output energy @
10600 nm | Max 251mJ | 120 (30W model)
240 mJ (70W model) | Differences do not
affect safety and
effectiveness. | | Output energy @
1570 nm | Max 144mJ | 24mJ-144 mJ/pixel | Identical | | Beam density @
10600 nm | 61% - 98% untreated
tissue between spots | ~63% - 97% untreated
tissue between spots | Differences do not
affect safety and
effectiveness. | | Beam density @
1570 nm | Up to 400 pixels/cm2 | Up to 390 pixels/cm2 | Differences do not
affect safety and
effectiveness. | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ {11}------------------------------------------------ ## Clinical Performance Data: None # Non-Clinical Performance Data: # Electrical safety and electromagnetic compatibility (EMC) Electrical safety and EMC testing were conducted on the Helix device, according to the following standards: . ANSI AAMI ES60601-1Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. {12}------------------------------------------------ . 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. # Software Validation and Verification Testing Software verification and validation testing were conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." # Additional non-clinical testing conducted Additional tests were conducted on the Helix device, 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: On the basis of the comparison with the predicate device and on the non-clinical performance data, we can conclude that DEKA HELIX is as safe, as effective, and performs as well as the legally marketed predicate device (K203441). # Additional Information: None --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K222221](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K222221) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com