(27 days)
No
The document describes a laser system for soft tissue procedures and mentions software that enables/disables features, but there is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
Yes
The device is indicated for "incision, ablation, vaporization and coagulation of body soft tissues," which are therapeutic actions. It also refers to "therapeutic laser equipment" in the performance standards.
No
This device is a CO2 laser system used for surgical procedures like incision, ablation, vaporization, and coagulation of soft tissues, indicating a therapeutic function, not a diagnostic one.
No
The device description explicitly details multiple hardware components including a laser console, articulated arm, footswitch, and various delivery devices and accessories. While it mentions proprietary software, the device is fundamentally a hardware system with embedded software for control and functionality.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is used for "incision, ablation, vaporization and coagulation of body soft tissues." This describes a direct interaction with living tissue within the body, which is characteristic of a therapeutic or surgical device, not an IVD.
- Device Description: The description details a laser system that delivers energy to tissue. This aligns with a surgical or therapeutic device.
- 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.
IVDs are used to perform tests on samples taken from the body, not to directly treat or alter tissue within the body.
N/A
Intended Use / Indications for Use
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.
Product codes
GEX
Device Description
The subject AcuPulse W system is a new scaled-down version of the recently FDA cleared Lumenis AcuPulse CO2 Laser System, Delivery Devices and Accessories under K180597. It is based on the following hardware components in the AcuPulse:
- . A Laser Console with a Free Beam Port to which an articulated arm attached.
- Identical to the AcuPulse, the Laser Console of the AcuPulse W System houses the laser O tube and optical system, the laser power source, console electronics, laser output ports, cooling system, purge air pump, control components (including touch screen, emergency stop button) and rear connector panel.
- . An articulated arm to guide laser output via a set of folding mirrors to the connected accessory for delivery of laser energy to the tissue.
- . 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 AcuPulse and AcuPulse W systems have the same proprietary software, which is embedded in the Main Controller, Peripheral Controller units and PC. The differences between the two are the enabled or disabled software features, through a hardware key (HASP dongle), that reflects the capabilities of each laser system or the particular configuration of a given system. Importantly, both systems use the same Software version, which was already validated, verified and submitted under K180597.
The AcuPulse W is offered with a subset of the previously cleared AcuPulse Handpieces/Tips that connect to the articulated arm or/and scanners for controlled delivery of laser energy to the target tissue. In addition, Lumenis is adding a Titanium (Ti-6Al-4V) 90° Side-firing Handpiece design. Like the cleared handpieces, it has multiple uses. The 90° Side-firing handpiece connects to the cleared 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
- Tip (Standard or Fine)
- . Limiter ring (Standard or Fine)
This handpiece is based on the same technology and principles of operation of the cleared CO2 delivery devices and its introduction does not raise any new questions of safety and/or efficacy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body soft tissues, skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thoracic surgery.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 modifications introduced. The test methods are essentially the same as those used to support to the clearance of the AcuPulse CO2 Laser System, Delivery Devices and Accessories (K082809, K100415, K180597).
The following activities were performed:
- . Risk analysis (ISO 14971)
- Electrical and laser safety and electromagnetic compatibility testing as required to conform . to performance standards as follows:
- IEC 60601-1: Medical electrical equipment Part 1: General requirements for o basic safety and essential performance
- IEC 60601-1-2: Medical electrical equipment Part 1-2: General requirements for o basic safety and essential performance- Collateral standard: Electromagnetic compatibility- requirements and tests
- IEC 60825-1: Safety of laser Products-Part 1: Equipment classification and o requirements
- IEC 60601-2-22: Medical electrical equipment- part 2: particular requirements for o the safety of diagnostic and therapeutic laser equipment.
- . 90° Side-firing Handpiece testing demonstrating demonstrate that the accessory together with the AcuPulse W system performs in compliance with their specifications and requirements
- 90° Side-firing Handpiece Cleaning (AAMI TIR 30) and sterilization validation activities (ISO ● 17665-1)
- 90° Side-firing Handpiece Biocompatibility of materials (ISO 10993) .
Test results indicated that the new configuration AcuPulse W CO2 Laser System, Delivery Devices and accessories perform in accordance with its requirements and specifications similarly to its predicate device. Consequently, Lumenis Ltd. believes that 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K133895, K101555, K063001, K160312, K172096, K082809, K100415
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
July 16, 2020
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
Lumenis Ltd. Shlomit Segman Senior Manager RA 6 Hakidma Street PO Box 240 Yokneam, 2069204 Israel
Re: K201663
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: June 15, 2020 Received: June 19, 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.
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
1
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 (OS) 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,
Colin Kejing Chen 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K201663
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.
| 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) |
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3
K201663
510(k) SUMMARY
The Lumenis AcuPulse W Laser System, Delivery Devices and Accessories
| Applicant Name: | Lumenis Ltd.
6 Hakidma Street PO Box 240
Yokneam Industrial Park,
Yokneam 2069204, Israel
Tel: +972-4-9599000
Fax: +972-4-9599046 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Shlomit Segman Lumenis Ltd.
6 Hakidma Street PO Box 240,
Yokneam Industrial Park,
Yokneam 2069204, Israel
Tel: +972-4-9599230
Fax: +972-4-9599198
Email:Shlomit.Segman@lumenis.com |
| Date Prepared: | 15 June 2020 |
| Trade Name: | The 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 Family of CO2Lasers system (K180597) |
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.
4
Device Description:
The subject AcuPulse W system is a new scaled-down version of the recently FDA cleared Lumenis AcuPulse CO2 Laser System, Delivery Devices and Accessories under K180597. It is based on the following hardware components in the AcuPulse:
- . A Laser Console with a Free Beam Port to which an articulated arm attached.
- Identical to the AcuPulse, the Laser Console of the AcuPulse W System houses the laser O tube and optical system, the laser power source, console electronics, laser output ports, cooling system, purge air pump, control components (including touch screen, emergency stop button) and rear connector panel.
- . An articulated arm to guide laser output via a set of folding mirrors to the connected accessory for delivery of laser energy to the tissue.
- . 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 AcuPulse and AcuPulse W systems have the same proprietary software, which is embedded in the Main Controller, Peripheral Controller units and PC. The differences between the two are the enabled or disabled software features, through a hardware key (HASP dongle), that reflects the capabilities of each laser system or the particular configuration of a given system. Importantly, both systems use the same Software version, which was already validated, verified and submitted under K180597.
The AcuPulse W is offered with a subset of the previously cleared AcuPulse Handpieces/Tips that connect to the articulated arm or/and scanners for controlled delivery of laser energy to the target tissue. In addition, Lumenis is adding a Titanium (Ti-6Al-4V) 90° Side-firing Handpiece design. Like the cleared handpieces, it has multiple uses. The 90° Side-firing handpiece connects to the cleared 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
- Tip (Standard or Fine)
- . Limiter ring (Standard or Fine)
This handpiece is based on the same technology and principles of operation of the cleared CO2 delivery devices and its introduction does not raise any new questions of safety and/or efficacy.
Substantial Equivalence
The intended use of the AcuPulse W System is a shortened version of the cleared AcuPulse, with the changes to reflect the reduced options proposed for the AcuPulse W System and to follow the format that we have noted for the reference, competing device DEKA SmartXide2 (K133895) and other cleared CO2 laser systems (see also K101555, K063001, K160312 and K172096).
5
In addition, the same technological characteristics and principles of operation apply for all laser systems, Delivery Devices and accessories.
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 modifications introduced. The test methods are essentially the same as those used to support to the clearance of the AcuPulse CO2 Laser System, Delivery Devices and Accessories (K082809, K100415, K180597).
The following activities were performed:
- . Risk analysis (ISO 14971)
- Electrical and laser safety and electromagnetic compatibility testing as required to conform . to performance standards as follows:
- IEC 60601-1: Medical electrical equipment Part 1: General requirements for o basic safety and essential performance
- IEC 60601-1-2: Medical electrical equipment Part 1-2: General requirements for o basic safety and essential performance- Collateral standard: Electromagnetic compatibility- requirements and tests
- IEC 60825-1: Safety of laser Products-Part 1: Equipment classification and o requirements
- IEC 60601-2-22: Medical electrical equipment- part 2: particular requirements for o the safety of diagnostic and therapeutic laser equipment.
- . 90° Side-firing Handpiece testing demonstrating demonstrate that the accessory together with the AcuPulse W system performs in compliance with their specifications and requirements
- 90° Side-firing Handpiece Cleaning (AAMI TIR 30) and sterilization validation activities (ISO ● 17665-1)
- 90° Side-firing Handpiece Biocompatibility of materials (ISO 10993) .
Test results indicated that the new configuration AcuPulse W CO2 Laser System, Delivery Devices and accessories perform in accordance with its requirements and specifications similarly to its predicate device. Consequently, Lumenis Ltd. believes that 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.