Thulium Fiber Laser (FiberLAZE+, FiberLAZE)

K242987 · Allengers Global Healthcare Private Limited · GEX · Dec 17, 2024 · General, Plastic Surgery

Device Facts

• Record ID: K242987
• Device Name: Thulium Fiber Laser (FiberLAZE+, FiberLAZE)
• Applicant: Allengers Global Healthcare Private Limited
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 17, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Thulium Fiber Laser is intended for incision, resection, ablation, vaporization, coagulation, and haemostasis of soft tissue in the following indications: Urology, Lithotripsy, Gastroenterological surgery and Gynecological Surgery.

Device Story

Thulium Fiber Laser is a surgical laser system emitting 1.94 µm wavelength radiation to perform soft tissue incision, resection, ablation, vaporization, coagulation, and haemostasis. The device consists of a laser source, power electronics, control electronics, cooling system, and an optical fiber delivery system. The operator (physician) triggers laser emission via a footswitch. Software controls device functions and user-selected settings. Used in clinical settings (urology, gastroenterology, gynecology) for procedures ranging from prostate surgery and lithotripsy to open/laparoscopic abdominal surgeries. The laser energy is delivered to the target tissue via an optical fiber, allowing for precise tissue interaction. The device benefits patients by providing a minimally invasive or endoscopic surgical tool for various soft tissue pathologies and stone fragmentation, potentially reducing surgical trauma compared to traditional methods.

Clinical Evidence

Bench testing only. The device underwent verification and validation testing in accordance with recognized consensus standards, including ISO 14971 (risk management), IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-2-22 (laser safety), and IEC 62366-1 (usability). Software verification and validation were performed per FDA guidance.

Technological Characteristics

Thulium fiber laser (DPSS); 1.94 µm wavelength; 60W/35W max power; pulsed/CW emission; 0.1-15ms pulse duration; 1-2500 Hz frequency; 0.02-6J pulse energy. Includes 532nm aiming beam (<5mW). Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-6, and IEC 62366-1.

Indications for Use

Indicated for soft tissue incision, resection, ablation, vaporization, coagulation, and haemostasis in urology (BPH, LRP, LEP, LAP, TUIP, condylomas, strictures, tumors, calculi fragmentation), lithotripsy (ureteral, bladder, renal calculi), gastroenterology (appendectomy, polyps, cancer, ulcers, varices, etc.), and gynecology (open/laparoscopic 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

• Fiber Dust (K210142)

Reference Devices

• Soltive Laser System (K183647)

Submission Summary (Full Text)

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December 17, 2024

Allengers Global Healthcare Private Limited Harpreet Singh Director-Technical Room No.5, Khasra no. 79, Bhankarpur, Mubarakpur Road District- Mohali Derabassi. Punjab 140507 India

Re: K242987

Trade/Device Name: Thulium Fiber Laser (FiberLAZE+, FiberLAZE) 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 19, 2024 Received: September 26, 2024

Dear Harpreet Singh:

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 (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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.

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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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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

Sincerely.

TANISHA L Digitally signed by Date: 2024.12.17 HITHE S 21:57:32 -05'00' Tanisha Hithe 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

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K242987

Device Name

Thulium Fiber Laser (FiberLAZE+, FiberLAZE)

#### Indications for Use (Describe)

Thulium Fiber Laser is intended for incision, resection, ablation, vaporization, coagulation, and haemostasis of soft tissue in the following indications: Urology, Lithotripsy, Gastroenterological surgery and Gynecological Surgery.

Urologv

- · 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, resection, ablation, vaporization, coagulation and haemostasis) including:

- · Appendectomy
- · Angiodysplasia
- · Polyps
- · Colorectal cancer
- · Biopsy
- · Telangiectasias
- •Gall Bladder calculi
- · Telangiectasias of the Osler-Weber-Renu disease
- · Biliary/Bile duct calculi
- · Vascular Malformation
- · Ulcers
- · Gastritis
- · Gastric ulcers
- · Esophagitis
- · Duodenal ulcers
- · Esophageal ulcers

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- Non Bleeding Ulcers
- Varices
- Pancreatitis
- Colitis
- Haemorrhoids
- Mallory-Weiss tear
- Cholecystectomy
- Gastric Erosions
- Benign and Malignant Neoplasm

Gynecology

Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue

*Type of Use (Select one or both, as applicable)*

| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |
|----------------------------------------------------------------------------------|----------------------------------------------------------------------|
|----------------------------------------------------------------------------------|----------------------------------------------------------------------|

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# 510(k) SUMMARY

## (K242987)

This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92

| Applicant /Manufacturer<br>Name and Address | Room No.5, Khasra no. 79, Bhankarpur, Mubarakpur Road, Derabassi,<br>District- Mohali, 140507, Punjab (India)<br>[phone] |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|

#### Harpreet Singh

Address: Room No.5, Khasra no. 79, Bhankarpur, Mubarakpur Road, Derabassi, District- Mohali, 140507, Punjab (India) 510(K) Contact person Contact Number: [phone] Email ID: [e-mail]:[e-mail]

- Date Prepared 15 September,2024 Thulium Fiber Laser Device/Trade Name FiberLAZE+, FiberLAZE Models Names Class II Regulation Class Laser Surgical Instrument For Use In General And Plastic Surgery And Regulation Name In Dermatology Regulation Number 21 CFR 878.4810 Product Code GEX Panel General and Plastic Surgery Predicate Device Fiber Dust (K210142) -Quanta system SpA Reference Device Soltive Laser System(K183647)-Olympus Surgical Technologies America

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### Device Description

Thulium Fiber Laser is a laser system that emits a wavelength of 1.94 um with a laser output power up to 60W and 35W respectively. Laser radiation is delivered to the patient via an optical fiber.

The main subsystems of the device are the laser, the power electronics, the optical delivery system, the control electronics, and the cooling system. Software controls the device functions and allows the user select device settings. Laser emission is triggered by a footswitch.

#### Accessories

The device is intended to be used together with delivery optical fiber that separately received a FDA clearance for an intended use.

#### Intended Use/ Indications for Use:

Thulium Fiber Laser is intended for incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue 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

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#### Gastroenterology

Open and endoscopic gastroenterology surgery (incision, resection, ablation, vaporization, coagulation and haemostasis) including:

- Appendectomy .
- Angiodysplasia .
- Polyps ●
- Colorectal cancer ●
- Biopsy .
- Telangiectasias ●
- •Gall Bladder calculi ●
- Telangiectasias of the Osler-Weber-Renu disease
- Biliary/Bile duct calculi .
- Vascular Malformation .
- Ulcers ●
- Gastritis ●
- Gastric ulcers .
- Esophagitis ●
- Duodenal ulcers .
- Esophageal ulcers ●
- Non Bleeding Ulcers ●
- Varices .
- Pancreatitis ●
- Colitis ●
- Haemorrhoids .
- Mallory-Weiss tear .
- Cholecystectomy .
- Gastric Erosions ●
- . Benign and Malignant Neoplasm

#### Gynecology

Open and laparoscopic gynecological surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue

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#### Comparison with predicate device

The subject device technological characteristics and indication for use are same to the predicate device.

Other differences between the subject device and predicate device not raise new types of question regarding the subject device's safety and efficacy.

#### Summary of Technical Characteristic

| Feature | Subject Device<br>Allengers Global Healthcare Pvt.<br>Ltd. | Subject Device<br>Allengers Global Healthcare Pvt.<br>Ltd. | Predicate Device<br>Quanta System SpA | Justification<br>for differences |
|--------------------------|------------------------------------------------------------|------------------------------------------------------------|---------------------------------------|----------------------------------|
| Manufacturer | | | | |
| Models | FiberLAZE+ | FiberLAZE | Fiber Dust | NA |
| 510(k) | K242987 | | Fiber Dust (K210142) | NA |
| Manufacturer | Allengers Global Healthcare Pvt.<br>Ltd. | | Quanta System SpA | NA |
| Device Name | Thulium Fiber Laser | | Fiber Dust | NA |
| Laser Medium | Thulium Laser | | Thulium Laser | Same |
| Wavelength | 1.94 µm | | 1.94 µm | Same |
| Emission | Pulsed/CW | | Pulsed/CW | Same |
| Pulse Duration | 0.1 to 15ms | | 0.1 to 15ms | Same |
| Pulse Frequency | 1 to 2500 Hz | 1 to 1600 Hz | 1 to 2500 Hz | Similar |
| Pulse Energy | 0.02 to 6J | | 0.02 to 6J | Same |
| Maximum<br>Average Power | 60 W | 35W | 60 W | Similar |
| Delivery System | Optical Fiber | | Optical Fiber | Same |
| Type | DPSS | | DPSS | Same |
| Power | Power <5mW | | Power <5mW | Same |
| Wavelength | Wavelength 532nm | | Wavelength 532nm | Same |
| Laser Class | Class 3R | | Class 3R | Same |

#### Performance Testing

The Subject device performs testing in accordance with the following recognized consensus standards

- Risk analysis activities, in compliance with the requirements of ISO 14971: 2019 Medical . devices - Application of Risk Management to Medical Devices.
- Electrical and laser safety and electromagnetic compatibility tests, in compliance with: .
- IEC 60601-1:2005+A1:2012+A2:2020 Medical Electrical Equipment Part 1: General O Requirements for Basic Safety and Essential Performance.
- IEC 60601-1-2:2014+A1:2020, Medical Electrical Equipment Part 1-2: General o Requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.

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## Allengers Global Healthcare Pvt. Ltd.

- O IEC 60601-2-22:2019 Medical Electrical Equipment -Part 2-22: Particular Requirements For Basic Safety And Essential Performance of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment.
- IEC 60825-1:2014 Safety of laser products Part 1: Equipment classification and o requirements.
- IEC 60601-1-6:2010+A1:2013+A2:2020 Medical Electrical Equipment Part 1-6: o General Requirements for Basic Safety and Essential Performance-collateral standard: Usability.
- IEC 62366-1:2015/AMD1:2020 Medical devices Part 1: Application of usability o engineering to medical devices
- Software verification and validations, in compliance with FDA "Content of Premarket Submissions ● for Device Software Functions" (issue on 2023). The tests verified that the subject Thulium Fiber Laser performs according to its specifications.

#### Conclusion

The Thulium Fiber Laser does not introduce any new indications for use, nor does the use of the systems result in any new potential hazard. The Thulium Fiber Laser, the subject device is substantially equivalent to the predicate device Fiber Dust (K210142).

The intended use, the design principle, and the applicable standards for the subject device are identical to those of the predicate. Some characteristics, for example, their appearance, user interface and the physical dimension are different. However performance test result demonstrates that these differences do not raise any new question of safety and effectives. Therefore, it is Allengers Global Healthcare Pvt. Ltd. opinion that the subject device appears to be as safe and effective as the predicate device.