(34 days)
Not Found
No
The document describes a laser system for surgical procedures and mentions software changes related to laser emission parameters. There is no mention of AI, ML, or any capabilities that would suggest the use of such technologies for image processing, diagnosis, or other functions.
Yes
The device is used for a variety of surgical procedures, including incision, resection, ablation, vaporization, coagulation, and haemostasis of soft tissue, addressing conditions in multiple medical specialties. These procedures are aimed at treating or alleviating medical conditions, which aligns with the definition of a therapeutic device.
No
The device description indicates its use in surgical procedures for incision, resection, ablation, vaporization, coagulation, and haemostasis of soft tissue, which are all therapeutic actions. There is no mention of it being used to diagnose conditions or diseases.
No
The device description explicitly states it is a "Litho laser system and its fiber optic delivery system," indicating it is a hardware device that uses software to control its parameters. The modifications are to the laser emission parameters, which are hardware-controlled functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical laser system used for procedures like incision, resection, ablation, vaporization, coagulation, and haemostasis of soft tissue and calculi within the body. These are all in vivo procedures, meaning they are performed on living tissue within the patient.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. The Litho laser system does not perform such tests.
- Device Description: The device description confirms it's a laser system with a fiber optic delivery system, designed for surgical intervention.
- Lack of IVD-related information: The document does not mention any analysis of biological samples, diagnostic testing, or any of the typical components or processes associated with IVD devices.
Therefore, the Litho laser system is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Litho laser system and its fiber optic delivery system are 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, Discectonly, 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 (BHP),
- · 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 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
- 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/Discectorny
Gynaecology
Open and laparoscopic gynaecological surgery (incision, resection, 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
- · Biopsy
Product codes
GEX
Device Description
This Special 510(k) of the modified device Litho is submitted due to Device Modifications of the already cleared device (K141101) due to the broadening of the range of some laser emission parameters such as power, energy and frequency.
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.
The modified and unmodified devices are exactly the same except for the available range of emission parameters. A change to the software determined the differences between the modified and unmodified versions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urethra, Bladder, Ureter, Prostate, External genitalia, Urethral, Bladder, Renal calculi (cystine, calcium oxalate monohydrate, calcium oxalate dehydrate stones), Kidney, Appendix, Colon (Polyps), Gallbladder, Biliary/Bile duct, Stomach (Ulcers, Gastric ulcers, Erosions), Duodenum (Duodenal ulcers), Pancreas, Hemorrhoids, Angiodysplasia (Gastrointestinal), Colorectal, Telangiectasias (including Osler-Weber-Rendu disease), Vascular Malformation (Gastrointestinal), Esophagus (Esophagitis, Esophageal ulcers, Varices), Colon, Mallory-Weiss tear, Joints (small and large, excluding spine), Ligaments, Tendons, Articular surfaces, Knee (Capsule, Chondroplasty, Synovial tissue, Chondromalacia, Plica), Meniscus, Lumbar discs (L4-5, L5-SI), Cervical discs, Thoracic discs, Female reproductive organs, Nasal cavity, Sinuses (Endonasal/sinus), Turbinates, Lacrimal sac/nasal cavity connection (Dacryocystorhinostomy), Frontal sinus, Ethmoid sinus, Maxillary sinus, Skin, Internal organs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The modified device Litho 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. Medical Electrical Equipment Part 1: General Requirements For -Basic Safety And Essential Performance
- -IEC 60601-1-2 Edition 3: 2007-03, 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 Third Edition 2007-05, 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 Edition 2.0 2007-03, Safety Of Laser Products Part 1: Equipment Classification, And Requirements
The modified device Litho passed all the required testing and is in compliance will all applicable sections of the above mentioned performance standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES - USA
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 16, 2018
Ouanta System S.p.A. Francesco Dell'antonio V.P Regulatory Affairs & Quality Assurance Via acquedotto. 109 Samarate, 20826 Italy
Re: K163009
Trade/Device Name: Litho 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: November 3, 2016 Received: November 4, 2016
Dear Francesco Dell'antonio:
This letter corrects our substantially equivalent letter of December 1, 2016.
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. 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
Page 2 - Francesco Dell'antonio
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Jennifer R. Stevenson -S3
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K163009
Device Name Litho
Indications for Use (Describe)
The Litho laser system and its fiber optic delivery system are 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, Discectonly, 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 (BHP),
- · 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 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
FORM FDA 3881 (1/14)
3
· 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/Discectorny
Gynaecology
Open and laparoscopic gynaecological surgery (incision, resection, 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
FORM FDA 3881 (1/14)
4
· 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
- · Biopsy
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
ا_ 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
5. Special 510(K) SUMMARY – Device Modifications
Introduction:
This document contains the 510(k) Summary for the device Litho. The basis of this submission is Modifications to a Device already cleared. The content of this summary is based on the requirements of 21 CFR 807.92(c).
| Applicant / Manufacturer Name and Address: | Quanta System SPA
Via Acquedotto, 109
Samarate (VA)
Italy, 21017 |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact Person: | Francesco Dell'Antonio
Vice President Regulatory Affairs and QA
Quanta System SPA
Email: francesco.dellantonio@quantasystem.com
Phone: +39-0331-376797
Fax: +39-0331-367815 |
| Date Prepared: | October 26 th 2016 |
| Device Name: | Litho |
| Classification: | Class II |
| Classification Name: | Laser surgical instrument for use in general and plastic
surgery and in dermatology. |
| Regulation Number: | 21 CFR 878.4810 |
| Product Code: | GEX |
| Basis for Submission: | Device modifications |
| Legally Marketed Device | Litho (K141101) - Quanta System SPA
Lumenis Pulse 120h (K140388) - Lumenis LTD |
Performance Standards:
There are no mandatory performance standards for this device.
6
Description of the modifications:
This Special 510(k) of the modified device Litho is submitted due to Device Modifications of the already cleared device (K141101) due to the broadening of the range of some laser emission parameters such as power, energy and frequency.
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.
The modified and unmodified devices are exactly the same except for the available range of emission parameters. A change to the software determined the differences between the modified and unmodified versions.
There are not incremental changes from the original clearance K141101 to be taken into account other than the differences between modified and unmodified devices.
Based on the nature of the changes implemented, the device underwent and successfully passed electrical safety and performance testing according to IEC 60601-1 and its collateral standards.
Intended Use/Indications for Use
The modified device Litho has the same intended use of the unmodified device, as follows:
The LITHO laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, resection, ablation, vaporization, coaqulation and haemostasis of soft tissue 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 (BHP),
- . 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
5-2
7
- . 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
- Polvps .
- 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
- o 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:
ર-3
8
- 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, 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
- . Dacrvocystorhinostomy
- 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 .
- Biopsy .
9
Substantial Equivalence:
The modified and unmodified devices have the same components, the same laser sources and the same controlling principles, but some differences in the range of emission parameters.
Another predicate device, Lumenis Pulse 120h (K140388), has been considered in order to demonstrate the safety and effectiveness of the parameters combinations not included in the unmodified device.
The modified and unmodified devices have the same intended use.
Thus the modified device Litho is substantially equivalent to the previously legally marketed device, cleared under K141101.
Performace testing
The modified device Litho 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. Medical Electrical Equipment Part 1: General Requirements For -Basic Safety And Essential Performance
- -IEC 60601-1-2 Edition 3: 2007-03, 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 Third Edition 2007-05, 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 Edition 2.0 2007-03, Safety Of Laser Products Part 1: Equipment Classification, And Requirements
The modified device Litho passed all the required testing and is in compliance will all applicable sections of the above mentioned performance standards.