AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories

K202428 · Lumenis, Ltd. · GEX · Oct 22, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K202428
• Device Name: AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories
• Applicant: Lumenis, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 22, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Lumenis AcuPulse W CO2 Laser System, Delivery Devices and Accessories is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thoracic surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

Device Story

AcuPulse W CO2 laser system; scaled-down version of Lumenis AcuPulse family. System comprises laser console, articulated arm, footswitch, and various delivery devices/handpieces. Operates by transmitting laser energy to target tissue for soft tissue surgery. Used in clinical settings by physicians. Modification introduces disposable 90° side-firing handpiece tips to reduce infection risk; console, software, and core hardware remain unchanged from predicate. Output is controlled laser energy for tissue interaction. Benefits include precise tissue ablation/coagulation and reduced cross-contamination risk via single-use sterile tips.

Clinical Evidence

Bench testing only. No clinical data presented. Verification included risk analysis (ISO 14971), electrical safety (IEC 60601-1), performance verification, EO sterilization validation (ISO 11135-1), shelf-life validation, and biocompatibility (ISO 10993).

Technological Characteristics

CO2 laser system; articulated arm delivery. Disposable tips EO sterilized per ISO 11135-1; packaging per ISO 11607. Biocompatibility per ISO 10993. Electrical safety per IEC 60601-1. Software embedded in main/peripheral controllers. System includes console, footswitch, and handpieces (standard/fine focus).

Indications for Use

Indicated for incision, excision, ablation, vaporization, and coagulation of soft tissues in dermatology, plastic surgery, podiatry, ENT, gynecology, neurosurgery, orthopedics, general, and thoracic surgery. Includes ablative skin resurfacing when used with scanning unit.

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

• AcuPulse W CO2 Lasers System Delivery Devices and Accessories (K201663)

Reference Devices

• Lumenis Family of AcuPulse CO2 Laser System, Delivery Devices and Accessories (K180597)
• AcuPulse Family of CO2 Lasers (K100384)
• AcuPulse Family of CO2 Lasers (K130164)
• Lumenis cleared sterile and non-sterile Delivery Devices and Accessories (K082809)
• Lumenis cleared sterile and non-sterile Delivery Devices and Accessories (K100415)

Submission Summary (Full Text)

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October 22, 2020

Lumenis Ltd. Shlomit Segman Senior Manager RA 6 Hakidma Street PO Box 240 Yokneam, 2069204 Israel

#### Re: K202428

Trade/Device Name: AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories 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: August 19, 2020 Received: August 25, 2020

Dear Shlomit Segman:

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Purva Pandya 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)

K202428

Device Name

Lumenis AcuPulse W CO2 Laser System, Delivery Devices and Accessories

Indications for Use (Describe)

Lumenis AcuPulse W CO2 Laser System, Delivery Devices and Accessories is indicated for incision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thoracic surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Type of Use (Select one or both, as applicable)

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# K202428 510(k) SUMMARY

### The Modified Lumenis AcuPulse W Laser System, Delivery Devices and Accessories

| Applicant Name: | Lumenis Ltd.<br>6 Hakidma Street PO Box 240<br>Yokneam Industrial Park,<br>Yokneam 2069204, Israel<br>Tel: [phone]<br>Fax: [phone] |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Shlomit Segman Lumenis Ltd.<br>6 Hakidma Street PO Box 240,<br>Yokneam Industrial Park,<br>Yokneam 2069204, Israel<br>Tel: [phone]<br>Fax: [phone]<br>Email:[e-mail] |
| Date Prepared: | 19 August 2020 |
| Trade Name: | Lumenis AcuPulse W Laser System, Delivery Devices and Accessories |
| Classification Name: | Powered laser surgical instrument |
| Product Code: | GEX |
| Device Class: | Class II |
| Regulation Number: | 21 CFR 878.4810 |
| Panel: | General & Plastic Surgery |
| Predicate Devices: | AcuPulse W CO2 Lasers System Delivery Devices and Accessories<br>(K201663) |

# Intended Use/ Indications for Use:

Lumenis AcuPulse W CO2 Laser System, Delivery Devices and Accessories is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thoracic surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

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# Device Description:

The AcuPulse W system (recently cleared under K201663) is a scaled-down version of the cleared Lumenis Family of AcuPulse CO2Laser System. Delivery Devices and Accessories under K180597. The modified AcuPulse W, identically to its predicate (K201663) is comprised of the following main functional components:

- A Laser Console with a Free Beam Port to which an articulated arm is attached .
- . A footswitch to activate the laser treatment beam and allow the selected laser energy to be transmitted via the delivery device to the target location.
- . A variety of Free Beam Delivery Device and accessories

The modified AcuPulse W and the cleared AcuPulse W (K201663) systems have the same proprietary software, which is embedded in the Main Controller, Peripheral Controller units and PC. Importantly, both systems use the same Software version, which was already validated, verified and submitted under K201663. Also, no changes to the Hardware were made to the svstem.

The AcuPulse W is offered with previously cleared AcuPulse Handpieces/Tips that connect to the articulated arm or/and scanners for controlled delivery of laser energy to the target tissue. Among them, the cleared 90° Side-firing Handpiece (K201663) connects to the AcuScan 120 Microscanner through two adaptors (a Handpiece Adapter and Third Lens Adapter) for delivery of laser energy. The 90° Side-firing Handpiece is comprised of the following components:

- . Handpiece Adapter (cleared under K201663)
- . Tip:
- Multiuse Standard Focus Tip (cleared under K201663) o
- Multiuse Fine Focus Tip (cleared under (K201663) о
- Disposable Standard Focus Tip (subject of this submission) o
- Disposable Fine Focus Tip ((subject of this submission) o
- . Limiter ring (cleared under K201663)

In this submission, Lumenis is introducing a disposable configuration of the 90° Side-firing Handpiece Tips in addition to the already cleared multiuse tips to respond to the increased market demand of disposable accessories for reducing the occurrence of treatment acquired infections. These 90° Side-firing Handpiece disposable tips are single use tips, packaged and EO sterilized, similarly to Lumenis devices previously cleared and used with the cleared AcuPulse Family of CO2Lasers (K100384 and K130164).

# Substantial Equivalence

The intended use of the Modified AcuPulse W System is identical to the cleared AcuPulse W System (K201663). The addition of the disposable configuration of 90° Side-firing handpiece Tips does not affect the intended use or mode of operation.

In addition, the system console and the rest of the accessories remained unchanged, i.e., no change to the software and system specifications. maintaining the identical technological characteristics and principles of operation as the cleared AcuPulse W laser system, Delivery Devices and accessories.

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Design verification processes were performed as a result of this risk analysis assessment to verify that no different questions of safety and effectiveness have been raised due to the addition of this disposable configuration of 90° Side-firing handpiece Tips. The test methods are essentially the same as those used to support to the clearance of the AcuPulse W and other Lumenis cleared sterile and non-sterile Delivery Devices and Accessories (K082809, K100415, K180597, K201663).

The following activities were performed:

- . Risk analysis per ISO 14971
- Electrical safety testing as required to conform to IEC 60601-1 standard. .
- o Performance verification and validation activities were conducted to evaluate that the 90° Side-firing Handpiece with the new disposable configuration of Tips performs according to its specifications.
- EO sterilization and Shelf-life validation activities for the new disposable configuration of the . 90° Side-firing Handpiece Tips were conducted by external laboratories. The test methods were essentially the same as those used to support the clearance of the cleared Sterile Fibers used with the AcuPulse Family of CO2 Laser System (cleared under K100384 and K130164), Testing results demonstrate compliance with ISO 11607, ISO 11135-1, and ISO 10993.
- The biocompatibility of the new disposable configuration of the 90° Side-firing Handpiece o Tips was evaluated to verify that the contact materials, identical to materials present in cleared predicate accessories (K100415), comply with ISO 10993 and FDA's quidance, Use of International Standard ISO 10993-1. "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing with a Risk Management Process."

Test results indicated that the AcuPulse W with the 90° Side-firing Handpiece equipped with the new configuration of disposable tips performs in accordance with its requirements and specifications similarly to its predicate device. Consequently, Lumenis Ltd. believes that the modified AcuPulse W CO2 Laser System, Delivery Devices and Accessories is substantially equivalent to the cleared predicate and it does not raise any different questions of safety and/or effectiveness.