The Litho EVO laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectory, Gynaecology, ENT and General Surgery.

Urology
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis) including:
· Urethral Strictures
· Bladder Neck Incisions (BNI)
· Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral Tumors,
· Ablation of Benign Prostatic Hypertrophy (BPH).
· Transurethral incision of the prostate (TUIP)
· Holmium Laser Resection of the Prostrate (HoLRP)
· Holmium Laser Enucleation of the Prostate (HoLEP)
· Holmium laser Ablation of the Prostate (HoLAP)
· Condylomas
· Lesions of external genitalia

Lithotripsy and Percutaneous Urinary Lithotripsy
· Endoscopic fragmentation of ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones.
· Endoscopic fragmentation of kidney 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
· Ulcers
· Gastric ulcers
· Duodenal ulcers
· Non Bleeding Ulcers
Pancreatitas
Haemorrhoids
· Cholecystectomy
Benign and Malignant Neoplasm
Angiodysplasia
Colorectal cancer
· Telangiectasias
· Telangiectasias of the Osler-Weber-Renu disease
Vascular Malformation
· Gastritis
· Esophagitis
Esophageal ulcers
Varices
· Colitis
· Mallory-Weiss tear
· Gastric Erosions

Arthroscopy
Arthroscopy/Orthopaedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) in small and large joints of the body, excluding the spine but including:
· Ligament and tendon Release
· Contouring and sculpting of articular surfaces
· Capsulectomy in the Knee
· Chondreplasty in the Knee
Debridement of inflamed synovial tissue
Chondromalacia Ablation
Chondromalacia and tears
· Plica Removal
· Meniscectomy
Loose Body Debridement
· Lateral retinecular release

Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including
· Percutaneous Laser Disc Decompression/Discectomy of the L4-5 and L5-SI lumbar discs, including Foraminoplasty Percutaneous Cervical Disc Decompression/Discectomy
Percutaneous Thoracic Disc Decompression/Discectomy

Gynaecology
Open and laparoscopic gynaecological surgery (incision, excision, ablation, vaporization, coagulation and haemostasis) of soft tissue

ENT
Endoscopic endonasal surgery (incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue and cartilage) including:
· Endonasal/sinus Surgery
· Partial turbinectomy
· Polypectomy
Dacryocystorhinostomy
Frontal Sinusotomy
Ethmoidectomy
· Maxillary antrostomy
· Functional endoscopic sinus surgery

General Surgery
Open, laparoscopic and endoscopic surgery (incision, resection, ablation, vaporization, coagulation and haemostasis) including:
· Appendectomy
Skin incision
· Excision of external and internal lesions
· Complete of partial resection of internal organs, tumors and lesions
Biopsv

Device Description

Litho Evo is based on Holmium laser cavity emitting at 2100nm. Laser emission is triggered by mean of a footswitch and is delivered to the tissue through fiber optics. The main parts (subsystems) of the subject device are the Holmium laser source, the optical delivery system, the power electronics, the control electronics and the cooling system. Moreover, a specific software controls the device functions and allows the user selections through the touchscreen display.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called Litho Evo, a Holmium laser system. This submission is a "Special 510(k)" due to modifications of an already cleared device, Olympus Empower H35 (K180426). The document states that performance testing and software verification and validation were conducted according to relevant standards. However, it does not provide a detailed study that proves the device meets specific acceptance criteria in terms of clinical performance or effectiveness.

Here's a breakdown of the requested information based only on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria for device performance in a clinical or measurable outcomes sense, nor does it report specific performance metrics (e.g., success rates, fragmentation efficiency, treatment times) for the Litho Evo device. Instead, it focuses on compliance with general safety and performance standards for medical electrical equipment and laser products.

Acceptance Criteria (Stated as Compliance with Standards)	Reported Device Performance (Stated as Compliance)
IEC 60601-1:2012, ed 3.1 (Basic Safety & Essential Performance)	Passed all required testing and is in compliance
IEC 60601-1-2 Ed 4: 2014 (EMC Requirements)	Passed all required testing and is in compliance
IEC 60601-2-22: 2012-10 ed 3.1 (Surgical Laser Equipment)	Passed all required testing and is in compliance
IEC 60825-1 Ed. 3.0 (2014) (Safety of Laser Products)	Passed all required testing and is in compliance
Software Verification and Validation Testing	Conducted and documentation provided as recommended by FDA guidance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe any specific human-subject or clinical "test set" for evaluating the performance of the Litho Evo device against acceptance criteria. The performance testing mentioned refers to technical compliance with engineering and safety standards, not clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The performance testing described is related to engineering and safety standards, not medical interpretation or clinical ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no mention of a test set requiring adjudication in the context of clinical performance.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The Litho Evo is a laser surgical instrument, not an AI-assisted diagnostic or interpretive device. Therefore, MRMC studies and AI effect sizes are not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a laser surgical instrument requiring human operation, not an autonomous algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for the performance testing mentioned appears to be defined by the technical specifications and requirements outlined in the cited IEC and FDA standards for safety, electromagnetic compatibility, and laser product safety.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI that would require a "training set" in the conventional sense. Software verification and validation were conducted, but this doesn't equate to an AI training set.

9. How the ground truth for the training set was established

Not applicable. (See #8)

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a circular seal with an abstract design of human figures. To the right of the seal, there is a blue square with the letters 'FDA' in white. Next to the blue square, the words 'U.S. FOOD & DRUG ADMINISTRATION' are written in a bold, sans-serif font. The words 'FOOD & DRUG' are on the top line, and the word 'ADMINISTRATION' is on the bottom line.

December 20, 2019

Quanta System SPA Francesco Dell'Antonio Vice President Regulatory Affairs and QA via Acquedotto 109 Samarate (Va), 21017 IT

Re: K192990

Trade/Device Name: Litho Evo 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 27, 2019 Received: October 25, 2019

Dear Francesco Dell'antonio:

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); 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 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}------------------------------------------------

Indications for Use

510(k) Number (if known) K192990

Device Name Litho EVO

Indications for Use (Describe)

Urology

Open and endoscopic surgery (incision, excision, resection, ablation,

vaporization, coagulation and haemostasis) including:
· Urethral Strictures
· Bladder Neck Incisions (BNI)
· Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral Tumors,
· Ablation of Benign Prostatic Hypertrophy (BPH).
· Transurethral incision of the prostate (TUIP)
· Holmium Laser Resection of the Prostrate (HoLRP)
· Holmium Laser Enucleation of the Prostate (HoLEP)
· Holmium laser Ablation of the Prostate (HoLAP)
· Condylomas
· Lesions of external genitalia

Lithotripsy and Percutaneous Urinary Lithotripsy

· Endoscopic fragmentation of ureteral, bladder and renal calculi including cystine, calcium oxalate,

monohydrate and calcium oxalate dehydrate stones.
· Endoscopic fragmentation of kidney 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
· Ulcers
· Gastric ulcers
· Duodenal ulcers
· Non Bleeding Ulcers
Pancreatitas
Haemorrhoids

FORM FDA 3881 (1/14)

{3}------------------------------------------------

· Cholecystectomy
Benign and Malignant Neoplasm
Angiodysplasia
Colorectal cancer
· Telangiectasias
· Telangiectasias of the Osler-Weber-Renu disease
Vascular Malformation
· Gastritis
· Esophagitis
Esophageal ulcers
Varices
· Colitis
· Mallory-Weiss tear
· Gastric Erosions

Arthroscopy

Arthroscopy/Orthopaedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) in small and large joints of the body, excluding the spine but including:

· Ligament and tendon Release
· Contouring and sculpting of articular surfaces
· Capsulectomy in the Knee
· Chondreplasty in the Knee
Debridement of inflamed synovial tissue
Chondromalacia Ablation
Chondromalacia and tears
· Plica Removal
· Meniscectomy
Loose Body Debridement
· Lateral retinecular release

Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including

· Percutaneous Laser Disc Decompression/Discectomy of the L4-5 and L5-SI lumbar discs, including Foraminoplasty Percutaneous Cervical Disc Decompression/Discectomy
- Percutaneous Thoracic Disc Decompression/Discectomy

Gynaecology

Open and laparoscopic gynaecological surgery (incision, excision, ablation, vaporization, coagulation and haemostasis) of soft tissue

ENT

Endoscopic endonasal surgery (incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue and cartilage) including:

· Endonasal/sinus Surgery
· Partial turbinectomy
· Polypectomy
Dacryocystorhinostomy
Frontal Sinusotomy
Ethmoidectomy
· Maxillary antrostomy

{4}------------------------------------------------

· Functional endoscopic sinus surgery

General Surgery

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

· Appendectomy
Skin incision
· Excision of external and internal lesions
· Complete of partial resection of internal organs, tumors and lesions
Biopsv

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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."

{5}------------------------------------------------

K192990 510(K) SUMMARY

Applicant /ManufacturerName and Address:	Quanta System SPAVia Acquedotto, 109Samarate (VA)Italy, 21017
510(k) Contact Person:	Francesco Dell'AntonioVice President Regulatory Affairs and QAQuanta System SPA
	Email: francesco.dellantonio@quantasystem.comPhone: +39-0331-376797Fax: +39-0331-367815
Date Prepared:	27th September 2019
Common name:	Holmium laser device
Brand name:	Litho Evo
Classification:	Class II
Classification Name:	Laser surgical instrument for use in general and plastic surgeryand in dermatology.
Regulation Number:	21 CFR 878.4810
Product Code:	GEX
Basis for Submission:	Device modifications
Legally Marketed Device:	Olympus Empower H35 (K180426) – Quanta System SPA
Reference predicate device:	Litho 100 (K180922) – Quanta System SPA

The modified device Litho Evo is derived from the legally marketed (unmodified) device Olympus Empower H35 (K180426).

Performance Standards:

There are no mandatory performance standards for this device.

{6}------------------------------------------------

Description of the device:

Litho Evo is based on Holmium laser cavity emitting at 2100nm.

Laser emission is triggered by mean of a footswitch and is delivered to the tissue through fiber optics. The main parts (subsystems) of the subject device are the Holmium laser source, the optical delivery system, the power electronics, the control electronics and the cooling system.

Moreover, a specific software controls the device functions and allows the user selections through the touchscreen display.

Description of the modifications:

This Special 510(k) of Litho Evo is submitted due to Device Modifications of the already cleared device Olympus Empower H35 (K180426) due to some technical modifications.

The subject device has the same technological characteristics (design, material, components, energy source) as the predicate device except for the differences shown in the table below.

	Subject device Litho Evo	Main predicate deviceEmpower H35	Reference predicatedevice Litho 100
Externalappearance	Cosmetic change from themain predicate	-	-
Graphic userinterface andsoftware	Same as the referencepredicate	-	-
Footswitch	Double footswitch, Same asthe reference predicate	Single footswitch	Double footswitch
Hardware,components andperformances	Same as main predicate	-	-

The modified device has the same intended use of the unmodified device. Moreover, the the intended use of the modified device, as described in its labeling, has not changed as a result of the modifications.

Based on the nature of the changes implemented, the device underwent and successfully passed performance testing and software verifications and validation according to the relevant standards.

A comparison of the technical characteristics of the subject device and its predicates follows:

	Subject device	Main predicate device	Reference predicate device
model name	Litho Evo	Empower H35	Litho 100
manufacturer	Quanta System SpA	Quanta System SpA	Quanta System SpA
510(k)	-	K180426	K180922
Laser Source	Pulsed Holmium laser(CHT:YAG)	Pulsed Holmium laser(CHT:YAG)	Pulsed Holmium laser(CHT:YAG)

{7}------------------------------------------------

	Subject device	Main predicate device	Reference predicatedevice
Wavelength(nm)	2.1 μm	2.1 μm	2.1 μm
Emission	pulsed	pulsed	pulsed
Pulseduration	Up to 1100µs	Up to 1500 µs	Up to 1100µs
Energy perpulse	up to 5.0 Joule	up to 5.0 Joule	up to 5.0 Joule
Frequency	from 3 to 30 Hz	from 3 to 30 Hz	from 3 to 80 Hz
Max averagepower	35 W	35 W	105W
Deliverysystem	Optical fibers	Optical fibers	Optical fibers
Aiming beam	green 532nm < 5mW	Green diode laser < 5 mW	Green diode laser < 5mW

Intended Use/Indications for Use

Litho Evo has the same intended use of the unmodified device, as follows:

The Litho Evo laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Gynaecology, ENT and General Surgery.

Urology

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

Urethral Strictures
Bladder Neck Incisions (BNI)
Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral Tumors, ●
Ablation of Benign Prostatic Hypertrophy (BPH),
Transurethral incision of the prostate (TUIP)
. Holmium Laser Resection of the Prostrate (HoLRP)
Holmium Laser Enucleation of the Prostate (HoLEP)
Holmium laser Ablation of the Prostate (HoLAP)
Condylomas
Lesions of external genitalia

Lithotripsy and Percutaneous Urinary Lithotripsy

{8}------------------------------------------------

Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, ● calcium oxalate, monohydrate and calcium oxalate dehydrate stones.
Endoscopic fragmentation of kidney 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
Ulcers
Gastric ulcers ●
Duodenal ulcers
Non Bleeding Ulcers
Pancreatitas
Haemorrhoids
Cholecystectomy
Benign and Malignant Neoplasm
Angiodysplasia
Colorectal cancer
Telangiectasias
Telangiectasias of the Osler-Weber-Renu disease
Vascular Malformation
Gastritis
Esophagitis
Esophageal ulcers
Varices
. Colitis
Mallory-Weiss tear ●
Gastric Erosions

Arthroscopy

Arthroscopy/Orthopaedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) in small and large joints of the body, excluding the spine but including:

. Ligament and tendon Release

{9}------------------------------------------------

Contouring and sculpting of articular surfaces
Capsulectomy in the Knee
Chondreplasty in the Knee
Debridement of inflamed synovial tissue
Chondromalacia Ablation
Chondromalacia and tears
Plica Removal
Meniscectomy
Loose Body Debridement
Lateral retinecular release

Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including

Percutaneous Laser Disc Decompression/Discectomy of the L4-5 and L5-SI lumbar discs, . including Foraminoplasty Percutaneous Cervical Disc Decompression/Discectomy Percutaneous Thoracic Disc Decompression/Discectomy

Gynaecology

Open and laparoscopic gynaecological surgery (incision, resection, ablation, vaporization, coagulation and haemostasis) of soft tissue

ENT

Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue and cartilage) including:

Endonasal/sinus Surgery
Partial turbinectomy
Polypectomy
Dacryocystorhinostomy
Frontal Sinusotomy
Ethmoidectomy
Maxillary antrostomy
Functional endoscopic sinus surgery

General Surgery

Open, laparoscopic and endoscopic surgery (incision, excision, ablation, vaporization, coagulation and haemostasis) including:

Appendectomy
Skin incision
Excision of external and internal lesions
Complete of partial resection of internal organs, tumors and lesions ●

{10}------------------------------------------------

. Biopsy

Performace testing

Litho Evo was subjected to performance testing in accordance with the following recognized consensus standards related to electromagnetic compatibility, electrical safety and performances:

-IEC 60601-1:2012, ed 3.1, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
। IEC 60601-1-2 Edition 4: 2014, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements And Tests.
-IEC 60601-2-22: 2012-10 ed 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 60825-1 Ed. 3.0 (2014) Safety of laser products - Part 1: Equipment classification and requirements
-Software verification and validation testing were conducted and 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".

Litho Evo passed all the required testing and is in compliance will all applicable sections of the abovementioned performance standards.

Comparison with predicate device:

The subject and unmodified devices have intended use and the same fundamental scientific technology, based on Holmium laser sources.

Summary

The modified device Litho Evo is substantially equivalent to its identified predicate device.

Regulation Number and Section

§ 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.