Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a laser system for soft tissue ablation and resurfacing, focusing on hardware components, wavelengths, and intended uses. There is no mention of AI or ML in the device description, intended use, or performance studies.

Therapeutic

Yes
The device is used for medical procedures such as laser skin resurfacing and the treatment of various skin conditions, which are considered therapeutic applications.

Diagnostic

No

Explanation: The device is described as a "Laser System" intended for surgical applications like ablation, vaporization, excision, incision, and coagulation of soft tissue. It is used for "laser skin resurfacing," "laser derm-abrasion," and "laser burn debridement." It does not mention any function related to diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly lists multiple hardware components including a laser system console, LCD control panel, articulated arm, footswitch, and delivery devices. While it mentions system software, it is clearly part of a larger hardware system.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue. This involves direct interaction with the patient's body for therapeutic purposes.
Device Description: The description details a laser system with various components designed for delivering laser energy to tissue.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.

IVD devices are used in vitro (outside the body) to analyze biological samples. This device operates in vivo (within the body) for surgical procedures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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
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, incision, 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.

Product codes

GEX, ONG

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)

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Soft tissue, skin

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Clinical Performance Data: None
Non-Clinical Performance Data: Electrical safety and electromagnetic compatibility (EMC) testing were conducted according to ANSI AAMI ES60601-1 and IEC 60601-1-2. Software verification and validation testing were conducted 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 was conducted according to IEC 60601-2-22 and IEC 60825-1.

Key Metrics

Not Found

Predicate Device(s)

K203441

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

Summary

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.

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