(259 days)
ERISE Laser Handpiece is indicated for use in soft tissue (skin and cutaneous tissue) such as, but not limited to: Dermatology and plastic Surgery: Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectas; Actinic chelitis; Keloids; Verrucae; Skin tags; Keratoses; Scar revision (including acne scars). With microbeam end piece it is indicated for Skin resurfacing.
ERISE is an Erbium:YAG laser handpiece delivering laser radiation at 2940nm. It is intended to be used with DEKA LUXEA platform, cleared by FDA with K192539. The Erise laser handpiece includes: - . A connector to connect to the console - A cord where electrical cables and hydraulic tubes pass in - A plastic shell - . A Laser cavity - . A mechanical shutter - . An optical guide - . An ending tip which provides different spot sizes (diameter 2, 4, 9mm), including microbeam output (diameter 9mm) The 2940 nm Erbium:YAG laser handpiece is controlled by the DEKA LUXEA console which it is connected to, through the connector.
The provided FDA 510(k) summary for the ERISE Laser Handpiece does not contain information about acceptance criteria for a device performance study or any study proving such criteria are met.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Quanta System 2940 nm Er:YAG laser handpiece) based on technological characteristics and non-clinical performance data.
Here's a breakdown of why the requested information cannot be provided from this document:
-
No Clinical Performance Data: The document explicitly states under "Clinical Performance Data:" "None". This means no studies were conducted to evaluate the device's clinical effectiveness in terms of specific outcomes or meeting pre-defined acceptance criteria for efficacy.
-
Focus on Substantial Equivalence: The primary goal of a 510(k) submission is to show that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing technological features, safety standards, and non-clinical performance, rather than conducting new clinical trials with acceptance criteria.
-
Non-Clinical Data for Safety and Compatibility: The "Non-Clinical Performance Data" section describes tests related to:
- Safety and electromagnetic compatibility (EMC): Compliance with standards like IEC 60601-2-22, IEC 60825-1 (for safety) and IEC 60601-1-2 (for EMC) for the DEKA LUXEA platform (which the ERISE handpiece connects to). These are regulatory compliance tests, not performance studies with acceptance criteria for specific clinical outcomes.
- Software Verification and Validation: This ensures the software of the DEKA LUXEA platform (with the ERISE handpiece) functions as intended. Again, this is a form of regulatory compliance and quality assurance, not a performance study evaluating clinical efficacy.
Therefore, it is not possible to complete the requested table or answer the specific questions about acceptance criteria and performance studies because such information is not present in this 510(k) submission. The device's approval is based on its similarity to an already cleared device and adherence to relevant safety and software standards, not on new clinical performance data demonstrating specific efficacy outcomes against predefined acceptance criteria.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left 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.
April 26, 2021
ELEN. Electronic Engineering Spa Paolo Peruzzi Regulatory Affair Manager Via Baldanzese 17 Calenzano, FI 50041 Italy
Re: K202258
Trade/Device Name: ERISE Laser handpiece 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 Dated: March 17, 2021 Received: March 23, 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.
{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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Purva Pandya 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) K202258
Device Name ERISE Laser Handpiece
Indications for Use (Describe)
ERISE Laser Handpiece is indicated for use in soft tissue (skin and cutaneous tissue) such as, but not limited to: Dermatology and plastic Surgery: Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectas; Actinic chelitis; Keloids; Verrucae; Skin tags; Keratoses; Scar revision (including acne scars). With microbeam end piece it is indicated for Skin resurfacing.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
{3}------------------------------------------------
510(K) Summary
ERISE Laser Handpiece
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:
April 15, 2021
Device Trade Name:
ERISE Laser handpiece
Common Name:
2940 nm Er:YAG laser handpiece
Classification:
Class II
Classification Name:
Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology
{4}------------------------------------------------
Product Code :
GEX
Classification Number:
21 CFR 878.4810
Predicate Device:
- K173002 – Quanta System 2940 nm Er:YAG laser handpiece
Device Description:
ERISE is an Erbium:YAG laser handpiece delivering laser radiation at 2940nm.
It is intended to be used with DEKA LUXEA platform, cleared by FDA with K192539.
The Erise laser handpiece includes:
- . A connector to connect to the console
- A cord where electrical cables and hydraulic tubes pass in
- A plastic shell
- . A Laser cavity
- . A mechanical shutter
- . An optical guide
- . An ending tip which provides different spot sizes (diameter 2, 4, 9mm), including microbeam output (diameter 9mm)
The 2940 nm Erbium:YAG laser handpiece is controlled by the DEKA LUXEA console which it is connected to, through the connector.
Indications for Use:
ERISE Laser Handpiece is indicated for use in soft tissue (skin and cutaneous tissue) such as, but not limited to: Dermatology and plastic Surgery: Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Anal tags; Keratoses; Scar revision (including acne scars).
With microbeam end piece it is indicated for Skin resurfacing.
{5}------------------------------------------------
Technological Characteristics Comparison:
ERISE laser handpiece is as safe, as effective, and performs as well as the legally marketed predicate device Quanta System 2940 nm Er:YAG laser handpiece (K173002):
| Proposed 510(k) Device | Predicate Device | |
|---|---|---|
| K173002 | ||
| Device Trade Name | ERISE laser handpiece | Quanta System 2940 nm Er:YAG laserhandpiece |
| Product code | GEX | GEX |
| Laser Wavelength | 2940 nm | 2940 nm |
| MAX Energy | 3 J | 3 J |
| Up to 95 J/cm2 (non microbeam mode); | Up to 95 J/cm2 (non microbeam mode); | |
| MAX Fluence | Up to 121 J/cm2 (with stacking pulses -microbeam mode) | Up to 121 J/cm2 (with stacking pulses -microbeam mode) |
| Handpiece Spot | Ø 2, 4, 9mm | Ø 2, 4, 9mm |
| Sizes | Ø 9mm dots array | Ø 9mm dots array |
| Pulse Duration | 0.3 to 1.5 ms | 0.3 to 1.5 ms |
| Pulse Repetition Rate | Up to 6 Hz | Up to 6 Hz |
| Diameter of the microbeams | 300- 600 μm | 300- 600 μm |
| Creation of microbeams | By microlenses array | By microlenses array |
| Number of dots | 65-70 | 65-70 |
| MAX Energy per Microbeam | 180 mJ (stacking mode) | 180 mJ (stacking mode) |
| Coverage of skin in microbeam mode | 12% | 12% |
Clinical Performance Data:
None
{6}------------------------------------------------
Non-Clinical Performance Data:
The following performance data are provided in support of the substantial equivalence determination, for the ERISE laser handpiece used in conjunction with DEKA LUXEA platform.
Safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the DEKA LUXEA platform.
The system complies with the IEC 60601-2-22, IEC 60825-1 standards for safety and the IEC 60601-1-2 standard for EMC.
Software Verification and Validation Testing
Software of DEKA LUXEA platform successfully underwent verification and validation testing including the use of ERISE Handpiece.
Software documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Conclusions:
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 ERISE Laser handpiece is as safe, as effective, and performs as well as the legally marketed predicate device.
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.