Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber Laser 1940 nm, OptiLITE Laser Fibers and Accessories

Q: Who is the manufacturer of Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber Laser 1940 nm, OptiLITE Laser Fibers and Accessories?

Convergent Laser Technologies filed the 510(k) submission for Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber Laser 1940 nm, OptiLITE Laser Fibers and Accessories (K211517).

Q: What is the FDA product code for Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber Laser 1940 nm, OptiLITE Laser Fibers and Accessories?

GEX. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

Q: What is the regulatory pathway for Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber Laser 1940 nm, OptiLITE Laser Fibers and Accessories?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber Laser 1940 nm, OptiLITE Laser Fibers and Accessories?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K211517 · Convergent Laser Technologies · GEX · Nov 9, 2021 · General, Plastic Surgery

Device Facts

Record ID	K211517
Device Name	Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber Laser 1940 nm, OptiLITE Laser Fibers and Accessories
Applicant	Convergent Laser Technologies
Product Code	GEX · General, Plastic Surgery
Decision Date	Nov 9, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Optica XT Thulium Fiber Laser and Accessories is intended for incision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.

Device Story

Optica XT Thulium Fiber Laser (1940 nm, 60W) delivers laser energy via fiber optic delivery system (150-1000 micron) to target soft tissue. Operated by physician via footswitch in clinical settings (urology, gastroenterology, gynecology). Device transforms electrical input (100-240 VAC) into laser energy for incision, resection, ablation, coagulation, hemostasis, and vaporization. Master/slave controller monitors laser power and verifies fail-safe conditions; system enters standby or shuts down upon error detection. Provides surgeons with precise tissue interaction for procedures like lithotripsy or prostatectomy; benefits patients through minimally invasive surgical capabilities.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including electrical safety (AAMI/ANSI ES60601-1), electromagnetic compatibility (IEC 60601-1-2), laser safety (IEC 60825-1), and biocompatibility (ISO 10993-1). Fiber performance verified via bending stress testing.

Technological Characteristics

Thulium fiber laser, 1940 nm wavelength, 60W output. Air-cooled, aluminum enclosure. Fiber delivery: quartz with silicone coating (150-1000 micron). Aiming beam: 532 nm, 3 mW. Electrical: 100-240 VAC, 50/60 Hz. Fail-safe: Master/slave controller. Standards: AAMI/ANSI ES60601-1, IEC 60825-1, IEC 60601-2-22, IEC 60601-1-2, IEC 60601-1-6, IEC 62304, ISO 10993-1.

Indications for Use

Indicated for soft tissue incision, resection, ablation, coagulation, hemostasis, and vaporization in urology (BPH, LRP, LEP, LAP, TUIP, condylomas, urethral strictures, genital lesions, BNI, tumor ablation/resection, lithotripsy), gastroenterology (appendectomy, polyps, biopsy, calculi, ulcers, pancreatitis, hemorrhoids, cholecystectomy, neoplasms, angiodysplasia, colorectal cancer, telangiectasias, vascular malformation, gastritis, esophagitis, varices, colitis, Mallory-Weiss tear, gastric erosions), and gynecology (open/laparoscopic soft tissue surgery).

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

SOLTIVE™ Laser System (SOLTIVETM Pro SuperPulsed Laser, SOLTIVETM Premium SuperPulsed Laser, SOLTIVETM Laser Fibers and Accessories) (K183647)

Related Devices

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K242191 — SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) · Olympus Surgical Technologies America · Aug 23, 2024
K221306 — SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories · Gyrus Acmi, Inc. · Jan 27, 2023
K220426 — Fiber Dust PRO · Quanta System Spa · Mar 16, 2022
K252787 — Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B) · Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · Nov 24, 2025

Submission Summary (Full Text)

{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. November 9, 2021 Convergent Laser Technologies Jennifer Mok Business Manager 1660 South Loop Road Alameda, California 94502 ## Re: K211517 Trade/Device Name: Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber Laser 1940 nm, OptiLITE Laser Fibers 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: September 14, 2021 Received: September 15, 2021 Dear Jennifer Mok: 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 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, 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) K211517 ### Device Name Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber Laser 1940 nm, OptiLITE Laser Fibers and Accessories ### Indications for Use (Describe) The Optica XT Thulium Fiber Laser and Accessories is intended for incision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery. Urology - · Ablation of Benign Prostatic Hyperplasia (Hypertrophy) [BPH] - · Laser Resection of the Prostrate (LRP) - · Laser Enucleation of the Prostate (LEP) - · Laser Ablation of the Prostate (LAP) - · Transurethral Incision of the Prostate (TUIP) - · Condylomas - · Urethral strictures - Lesions of external genitalia - · Bladder neck incisions (BNI) - · Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors - · Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi - · Treatment of distal impacted fragments remaining in the ureters following lithotripsy Lithotripsy and Percutaneous Urinary Lithotripsy Indications - · Endoscopic fragmentation of ureteral, bladder and renal calculi including cystine, calcium oxalate. - monohydrate and calcium oxalate dehydrate stones - Endoscopic fragmentation of renal calculi - · Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed ### Gastroenterology Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis) including: - · Appendectomy - · Polyps - · Biopsv - Gall Bladder calculi - Biliary/Bile duct calculi - · Ulcers - Gastric ulcers - · Duodenal ulcers - · Non Bleeding Ulcers - · Pancreatitis - Haemorrhoids - · Cholecystectomy - · Benign and Malignant Neoplasm - · Angiodysplasia - Colorectal cancer {3}------------------------------------------------ - · Telangiectasias - Telangiectasias of the Osler-Weber-Renu disease - Vascular Malformation - Gastritis - · Esophagitis - Esophageal ulcers - · Varices - Colitis - · Mallory-Weiss tear - · Gastric Erosions ### Gynecology Open and laparoscopic gynecological surgery (incision, excision, ablation, vaporization, coagulation and hemostasis) of soft tissue. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) ## 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." {4}------------------------------------------------ # 510(k) Summary #### I. General Information | Submitter/Manufacturer: | Xintec Corporation, dba, Convergent Laser Technologies 1660 South Loop Road Alameda, California 94502 | |-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Jennifer Mok Regulatory Affairs & Quality Assurance Manager Direct: 510-280-7207 Fax: 510-832-1600 | | Date Prepared: | October 28, 2021 | | II. Device | | | Trade/Device Name: | Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber Laser 1940 nm, OptiLITE Laser Fibers and Accessories | | Common or Usual Name | Surgical laser | | Classification Name: | Laser surgical instrument for use in general and plastic surgery and in dermatology (21 CFR 878.4810) | | Regulatory Class: | II | | Product Code: | GEX | | III. Predicate Device | | | Manufacturer | Olympus Surgical Technologies America | |--------------------|---------------------------------------------------------------------------------------------------------------------------------------------| | Trade/Device Name: | SOLTIVETM Laser System (SOLTIVETM Pro SuperPulsed Laser, SOLTIVETM Premium SuperPulsed Laser, SOLTIVETM Laser Fibers and Accessories) | | 510(k) Number | K183647 | | Regulatory Class: | II | | Product Code: | GEX | This predicate has not been subject to a design-related recall. No reference devices were used in this submission. {5}------------------------------------------------ #### IV. Device Description The Optica XT Thulium Fiber Laser is a thulium fiber laser radiation at 1940 nm with a laser output power of 60 Watts. Laser activation is by footswitch. The overall weight of the laser is 95 lbs., and the size is 20" W x 24" L x 16" H. The Optica XT Thulium Fiber Laser has an electrical requirement of 100-240 VAC, 50/60 Hz. Laser energy is delivered to the target site using a fiber optic delivery system with diameters from 150-1000 micron. #### V. Indications For Use The Optica XT Thulium Fiber Laser and Accessories is intended for incision, excision, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery. # Urology - Ablation of Benign Prostatic Hyperplasia (Hypertrophy) [BPH] ● - Laser Resection of the Prostrate (LRP) ● - Laser Enucleation of the Prostate (LEP) - Laser Ablation of the Prostate (LAP) - Transurethral Incision of the Prostate (TUIP) - Condylomas - Urethral strictures ● - Lesions of external genitalia - Bladder neck incisions (BNI) - Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors - Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi - Treatment of distal impacted fragments remaining in the ureters following lithotripsy # Lithotripsy and Percutaneous Urinary Lithotripsy Indications - Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, ● calcium oxalate, monohydrate and calcium oxalate dehydrate stones - Endoscopic fragmentation of renal calculi - Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed # Gastroenterology Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis) including: ● ● ● ● - . Appendectomy - Polyps - Biopsy - Gall Bladder calculi ● - Biliary/Bile duct calculi - Vascular Malformation ● Angiodysplasia Telangiectasias Colorectal cancer Telangiectasias of the Osler-Weber-Renu disease - Ulcers - Gastritis ● {6}------------------------------------------------ - Gastric ulcers ● - Duodenal ulcers - . Non Bleeding Ulcers - Pancreatitis - Haemorrhoids - Cholecystectomy - Benign and Malignant Neoplasm ● ## Gynecology Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue. #### VI. Comparison of Technological Characteristics The Optica XT Thulium Fiber Laser and Accessories share or similar indications for use, device operation, overall technical and functional capabilities, and therefore is the same or similar to the predicate device. The design and function of the Optica XT Thulium Fiber Laser and Accessories are similar to the predicate device for the modes of operation and use. ## Summary of the technological characteristics | Manufacturer | Convergent Laser Technologies | Olympus Surgical Technologies America | Significant Differences | |---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade/Device Name | Optica XT™ Thulium Fiber Laser and Accessories | SOLTIVE™ Laser Fibers, and Accessories | N/A | | 510(k) Number | K211517 | K183647 | N/A | | Product Code | GEX | GEX | Same | | CFR Citation Number | 21 CFR 878.4810 | 21 CFR 878.4810 | Same | | Classification | Class II | Class II | Same | | Generic/Common Name | Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology | Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology | Same | | Manufacturer | Convergent Laser Technologies | Olympus Surgical Technologies America | Significant Differences | | Trade/Device Name | Optica XTTM Thulium Fiber Laser and Accessories | SOLTIVETM Laser Fibers, and Accessories | N/A | | Electrical Power | 100-240 VAC, 50/60 Hz | 100-240 VAC, 50/60 Hz | Same | | Size of Components (H x W x L) | 16 x 20 x 24 inches | 11.6 x 14.6 x 22 inches | Similar; components may be larger and needs a larger enclosure. No additional safety or efficacy concern as the component configuration is similar for a working laser. | | Cooling | Air Cool | Air Cool | Same | | Aiming Beam | 532 nm, 3 mW | 500-550 nm, power adjustable 0-5 mW | Similar, within range of the predicate device | | Portability | Portable and can be placed on a medical cart | Portable and can be placed on a medical cart | Same | | Fail Safe Control System | Master and Slave controller to verify fail-safe control. Master and slave control to verify laser actions for error warning and fail-safe conditions. | Software Fail Safe Control System | Similar; both devices' fail-safe control system passed the Electrical Safety Testing. No safety or efficacy concern have been identified. | | Metal Enclosure | Aluminum enclosure | Aluminum enclosure | Same | | Manufacturer | Convergent Laser Technologies | Olympus Surgical Technologies America | Significant Differences | | Trade/Device Name | Optica XTTM Thulium Fiber Laser and Accessories | SOLTIVETM Laser Fibers, and Accessories | N/A | | Fiber Delivery Diameter | 150 micron - 1000 micron multimode fiber optic delivery | 150 micron - 1000 micron multimode fiber optic delivery | Same | | Fiber Length | 3 m | 3 m | Same | | Material of Fiber | Quartz, silicone protective coating | Quartz, silicone protective coating | Same | | Control Method | Laser power monitor and verification | Laser power monitor and verification | Similar, both devices' software and energy monitoring system passed the Electrical Safety Testing. No safety or efficacy concern have been identified. | | Laser Source | Thulium laser | Thulium laser | Same | | Wavelength | 1940 nm | 1920 – 1960 nm | Within the range of the predicate. | | Pulse Duration | 100 µs | 200 µs to 50 ms | Within the range of the predicate. | | Frequency | 5 to 1000 Hz | 1 to 2,400 Hz | Within the range of the predicate. | | Pulse Energy | 0.1 to 6 J | 0.025 to 6 J | Within the range of the predicate. | | Range of laser power | 60 Watts | 60 Watts | Same | | Manufacturer | Convergent Laser Technologies | Olympus Surgical Technologies America | Significant Differences | | Trade/Device Name | Optica XTTM Thulium Fiber Laser and Accessories | SOLTIVE™ Laser Fibers, and Accessories | N/A | | Weight | 43 kg | 40 kg | Similar, the device weighs more than the predicate device. Increased weight of the device does not add any concern or safety or efficacy. | | Training Program | Yes | Yes | Same | | Fail Safe Feature | Laser shuts down or go to STANDBY when detects failure or error | Laser shuts down or go to STANDBY when detects failure or error | Same | | Electrical Safety Testing | AAMI/ANSI ES 60601-1:2005+A1 IEC 60601- 1:2005+C1;C2;A1 | AAMI/ANSI ES 60601-1:2005+A1 IEC 60601-1:2005 | Same- AAMI/ANSI ES 60601-1:2005+A1 Similar, IEC 60601- 1:2005, both systems meet IEC 60601-1 standards, the device was tested based on the current standard at the time of testing. | | Electromagnetic Compatibility Testing | IEC 60601-1-2:2014, 4th Edition | IEC 60601-1-2:2007, 3rd Edition | Similar, both systems meet IEC 60601-1-2 standards, the device was tested based on the Edition current at the time of testing hence the Edition is not the same. | - Esophagitis ● - Esophageal ulcers ● - Varices ● - Colitis ● - Mallory-Weiss tear - Gastric Erosions {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ #### VII. Performance Data Non-clinical performance data support safety of the device in accordance to the following standards: - AAMI/ANSI ES60601-1:2005(R) 2012 and A1:2012, Medical Electrical Equipment Part 1: . General Requirements for Basic Safety and Essential Performance - IEC 60825-1:2014, Edition 3.0, Safety of Laser Products - Part 1: Equipment Classification and Requirements - IEC 60601-2-22:2012, Edition 3.1, Medical Electrical Equipment – Part 2-22: Particular Requirements for Basic Safety and Essential Performance of Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment - IEC 60601-1-2:2014, Edition 4, Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests - IEC 60601-1-6:2013, Edition 3.1, Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability - IEC 62304:2006, Ed. 1.0 + A1, Medical Device Software Software Life Cycle Processes ● Hardware and software verification and validation demonstrate that the Optica XT Thulium Fiber Laser and Accessories should perform as intended in the specified use conditions. Additionally, bench testing assessing the effect of bending stress on energy transmission in the optical fibers demonstrate comparable fiber performance. Biocompatibility is in compliance with ISO 10993-1 - Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process. Optical fibers demonstrate compliance for the following biological endpoints: - Cytotoxicity - . Acute systemic toxicity - Sensitization ● - Material-mediated pyrogenicity ● . Hemocompatibility - Irritation or intracutaneous reactivity This premarket submission for the Optica XT Thulium Fiber Laser and Accessories does not require clinical studies to support substantial equivalence. # VIII. Conclusions Based on the nonclinical testing conducted, the Optica XT is the same or similar to its predicate device in regards to EMC and electrical safety. The differences in technological characteristics between the Optica XT and predicate device present no new questions of safety or effectiveness for the "indications for use" specified. Thus, the Optica XT is as safe, as effective, and performs as well as the legally marketed predicate device.