(163 days)
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.
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)
The DEKA HELIX is a laser surgical instrument for use in general, plastic surgery, and dermatology. The acceptance criteria and the study that proves the device meets the acceptance criteria are detailed below, based on the provided FDA 510(k) summary (K222221).
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) submission primarily demonstrates substantial equivalence to a predicate device (Alma Hybrid Laser System, K203441) rather than explicitly defining and meeting specific analytical or clinical performance acceptance criteria in the format of a separate study. Instead, the "acceptance criteria" are implied through the comparison of the proposed device's characteristics and performance to those of the legally marketed predicate device, and through compliance with recognized electrical safety and laser safety standards.
The table below summarizes the comparison between the DEKA HELIX and its predicate device, highlighting where the proposed device is considered to be "as safe, as effective, and performs as well." Differences are noted as not affecting safety and effectiveness, implying performance within acceptable limits.
| Acceptance Criteria (Implied by Predicate Equivalence & Standards Compliance) | Reported Device Performance (DEKA HELIX) | Comment |
|---|---|---|
| Indications for Use (General) | Intended for surgical applications requiring ablation, vaporization, excision, incision, and coagulation of soft tissue in aesthetic surgery (dermatology and plastic surgery). Specific indications for CO2 handpieces and scanning unit are listed, including laser skin resurfacing for warts, acne scars, nevi epidermal, syringoma, and fractional skin resurfacing/coagulation with 1570 nm. | Identical to predicate device in overall scope. |
| Regulation Number | 21 CFR 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology | Identical |
| Product Code | GEX, ONG | Identical |
| System Control | Fully computerized | Identical |
| Emission Control | Footswitch, Interlock | Identical |
| User Interface | Touch-screen display, Emergency button, Key switch | Identical |
| Cooling System | Closed loop, heat exchanger | Identical |
| Emission Indicator | Visual, Audible | Identical |
| Electrical Requirements | 100-230 V, 16A 50/60 Hz, single phase | Differences do not affect safety and effectiveness. |
| Physical Dimensions and Weight | 62 cm x 63 cm x 138/202 cm (erected), ~ 70 Kg | Differences do not affect safety and effectiveness. |
| Laser Type | RF-excited CO2 laser, Class 4; Fiber Laser, Class 4 | Identical |
| CO2 Handpieces Wavelength | 10600 nm | Identical |
| CO2 Handpieces Pilot Beam | 635nm, 4mW | Differences do not affect safety and effectiveness. |
| CO2 Handpieces Spot Size (mm) | 0.125 – 2.0 mm | Differences do not affect safety and effectiveness. |
| CO2 Handpieces Pulse Duration | 10 - 900ms | Differences do not affect safety and effectiveness. |
| CO2 Handpieces Pulse Repetition Frequency | 0.2 — 200 Hz | Differences do not affect safety and effectiveness. |
| CO2 Handpieces Min Output Energy | 5 mJ | Identical |
| CO2 Handpieces Output Power | 70W | Differences do not affect safety and effectiveness (Predicate has 30W, 70W; Proposed has 70W). |
| Scanning Unit Wavelength | 10600 nm and/or 1570 nm | Identical |
| Scanning Unit Pilot Beam | 635nm, 4mW | Differences do not affect safety and effectiveness. |
| Scanning Unit Scanner | Dual axis scanner | Identical |
| Scanning Unit Tip | Cooled | Identical |
| Scanning Unit Spot Size @ 10600 nm | 0.374mm | Differences do not affect safety and effectiveness. |
| Scanning Unit Scan Size @ 1570 nm | 20x20 mm | Differences do not affect safety and effectiveness. |
| Scanning Unit Spot Size @ 1570 nm | 0.75mm | Identical |
| Scanning Unit Output Energy @ 10600 nm | Max 251mJ | Differences do not affect safety and effectiveness. |
| Scanning Unit Output Energy @ 1570 nm | Max 144mJ | Identical |
| Scanning Unit Beam Density @ 10600 nm | 61% - 98% untreated tissue between spots | Differences do not affect safety and effectiveness. |
| Scanning Unit Beam Density @ 1570 nm | Up to 400 pixels/cm2 | Differences do not affect safety and effectiveness. |
| Electrical Safety & EMC | Compliance with ANSI AAMI ES60601-1 and IEC 60601-1-2. | Testing conducted and documented. |
| Software Validation & Verification | Conducted and documented as recommended by FDA guidance. | Testing conducted and documented. |
| Laser Safety | Compliance with IEC 60601-2-22 and IEC 60825-1. | Testing conducted and documented. |
2. Sample Size Used for the Test Set and Data Provenance
No clinical performance data (human subject studies) were conducted for this 510(k) submission. Therefore, there is no "test set" in the context of clinical data for which a sample size or data provenance would be specified. The submission relies solely on non-clinical performance data and comparison to a predicate device.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Since no clinical performance data was used, there was no need for experts to establish ground truth for a test set.
4. Adjudication Method
Not applicable. No test set requiring adjudication was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The submission explicitly states "Clinical Performance Data: None."
6. Standalone Algorithm Performance Study
Not applicable. This device is a hardware laser system, not an AI algorithm, so there is no standalone algorithm performance to evaluate.
7. Type of Ground Truth Used
Not applicable. No clinical performance data was presented, so no ground truth from pathology, outcomes data, or expert consensus was required for direct device evaluation in this submission. The ground truth for proving safety and effectiveness relies on established engineering principles, international safety standards compliance, and the equivalence to a legally marketed predicate device.
8. Sample Size for the Training Set
Not applicable. As a hardware device with no AI algorithm, there is no "training set" in the machine learning sense. The development of the device likely involved engineering design, prototyping, and iterative testing, but this is distinct from an AI training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There was no training set in the context of machine learning.
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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: 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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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
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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.
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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
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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
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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 DeviceDEKA HELIX | Predicate DeviceThe Alma Hybrid LaserSystem (K203441) | Comment |
|---|---|---|---|
| Indications for Use | The Helix Laser Systemwith its accessories isintended for use insurgical applicationsrequiring the ablation,vaporization, excision,incision, and coagulationof soft tissue in medicalspecialties including:aesthetic surgery(dermatology and plastic | The Alma Hybrid LaserSystem, Delivery Devices,Applicators andAccessories are intendedfor use in surgicalapplications requiring theablation, vaporization,excision, incision, andcoagulation of soft tissuein medical specialtiesincluding: aesthetic | Identical |
| Device Trade Name | Proposed DeviceDEKA HELIX | Predicate DeviceThe Alma Hybrid LaserSystem (K203441) | Comment |
| surgery).CO2 handpiecesThe Helix CO2 handpieces,with wavelength of10600nm, are indicatedfor use for the particular | surgery (dermatology andplastic surgery).Hy-Light CO2The Alma Hybrid CO2 non-fractional applicator, withwavelength of 10600 nm is | ||
| indications as follows:Dermatology and PlasticSurgeryThe ablation, vaporization,excision, incision, and | cleared for use for theparticular indications asfollows:Dermatology & Plastic | ||
| coagulation of soft tissuein dermatology and plasticsurgery in theperformance of:*laser skin resurfacing*laser derm-abrasion | SurgeryThe ablation, vaporization,excision, incision, andcoagulation of soft tissuein dermatology and plasticsurgery in theperformance of: | ||
| *laser burn debridement.Laser skin resurfacing(ablation and/orvaporization) of soft tissue | * laser skin resurfacing* laser derm-abrasion* laser burn debridement. | ||
| for the reduction,removal, and/ortreatment of: warts, acnescars, nevi epidermal,syringoma.Vaporization/coagulationof warts. | Laser skin resurfacing(ablation and/orvaporization) of soft tissuefor the reduction,removal, and/ortreatment of: warts, acnescars, 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 | PixelThe 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. | ProScanThe Alma Hybrid ProScan CO2 fractional applicator, with wavelength of 10600 nm is indicated for:•Laser skin resurfacing (ablation and/or vaporization) of soft tissueThe 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 DeviceDEKA HELIX | Predicate DeviceThe Alma Hybrid LaserSystem (K203441) | Comment |
| CO2 &1570nm fractionalapplicator, withwavelengths of 10600 nm&1570nm is indicated forlaser skin resurfacing(ablation and/orvaporization) of softtissue. | |||
| Regulation number | 21 CFR 878.4810 Lasersurgical instrument foruse in general andplastic surgery and indermatology | 21 CFR 878.4810 Lasersurgical instrument foruse in general andplastic surgery and indermatology | Identical |
| Product Code | GEXONG | GEXONG | Identical |
| System Control | Fully computerized | Fully computerized | Identical |
| Emission Control | FootswitchInterlock | FootswitchInterlock | Identical |
| User Interface | Touch-screen displayEmergency buttonKey switch | Touch-screen displayEmergency buttonKey switch | Identical |
| Cooling System | Closed loop, heatexchanger | Closed loop, heatexchanger | Identical |
| Emission indicator | VisualAudible | VisualAudible | Identical |
| ElectricalRequirements | 100-230 V, 16A 50/60 Hz,single phase | 120 VAC, 11 A, 50/60 Hz,single phase220/230 VAC, 6 A, 50/60Hz, single phase | Differences do notaffect safety andeffectiveness. |
| Device Trade Name | Proposed DeviceDEKA HELIX | Predicate DeviceThe Alma Hybrid LaserSystem (K203441) | Comment |
| PhysicalDimensions andWeight | 62 cm x 63 cm x 138/202cm (erected)~ 70 Kg | 465mm x 533 mm x1345/1973 mm (erected)~ 86 Kg | Differences do notaffect safety andeffectiveness. |
| Laser Type | RF-excited CO2 laser, Class4Fiber Laser, Class 4 | RF-excited CO2 laser, Class4Fiber Laser, Class 4 | Identical |
| CO2 Handpieces | |||
| Wavelength | 10600 nm | 10600 nm | Identical |
| Pilot beam | 635nm, 4mW | 650 nm, 3mW | Differences do notaffect safety andeffectiveness. |
| Spot size (mm) | 0.125 – 2.0 mm | 0.15 – 3.0 at 50 mmworking distance0.25- 3.1 (Dia.) at 200 mmworking distance | Differences do notaffect safety andeffectiveness |
| Pulse Duration | 10 - 900ms | 1-1000 ms | Differences do notaffect safety andeffectiveness. |
| Pulse RepetitionFrequency | 0.2 — 200 Hz | 1 — 100 Hz | Differences do notaffect safety andeffectiveness. |
| Min output energy | 5 mJ | 5 mJ | Identical |
| Output Power | 70W | 30W, 70W | Differences do notaffect safety andeffectiveness. |
| Scanning unit | |||
| Wavelenght | 10600 nm and/or 1570nm | 10600 nm and/or 1570 nm | Identical |
| Pilot beam | 635nm, 4mW | 650 nm, 3mW | Differences do notaffect safety andeffectiveness. |
| Device Trade Name | Proposed DeviceDEKA HELIX | Predicate DeviceThe Alma Hybrid LaserSystem (K203441) | Comment |
| Scanner | Dual axis scanner | Dual axis scanner | Identical |
| Tip | Cooled | Cooled | Identical |
| Spot size @ 10600nm | 0.374mm | 0.35 mm@ 100 mmdistance | Differences do notaffect safety andeffectiveness. |
| Scan size @ 1570nm | 20x20 mm | Up to 30 mm diameter | Differences do notaffect safety andeffectiveness. |
| Spot size @ 1570nm | 0.75mm | 0.75 mm | Identical |
| Output energy @10600 nm | Max 251mJ | 120 (30W model)240 mJ (70W model) | Differences do notaffect safety andeffectiveness. |
| Output energy @1570 nm | Max 144mJ | 24mJ-144 mJ/pixel | Identical |
| Beam density @10600 nm | 61% - 98% untreatedtissue between spots | ~63% - 97% untreatedtissue between spots | Differences do notaffect safety andeffectiveness. |
| Beam density @1570 nm | Up to 400 pixels/cm2 | Up to 390 pixels/cm2 | Differences do notaffect safety andeffectiveness. |
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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.
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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.
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
§ 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.