The Auriga XL laser system including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in medical specialities including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery

Device Description

The Auriga XL is a holmium laser system, which emits laser radiation with a wavelength of approximately 2.1 um. The laser power transfers an optical application fiber. The indications are lithotripsy, dissection, ablation, resection and coagulation of tissue. The laser system consists of:

laser system including control panel (user interface)
foot switch
application fiber

AI/ML Overview

This submission is for a laser surgical instrument (Auriga XL) and does not describe acceptance criteria for a diagnostic device based on performance metrics such as sensitivity, specificity, or AUC. Instead, the performance testing focuses on compliance with established safety and performance standards for medical devices. Therefore, I cannot generate the requested table and information about elements such as sample size, expert qualifications, or comparative effectiveness studies.

Here's a breakdown of why along with the available information:

Reasoning for inability to provide requested details:

The provided text describes a 510(k) submission for a surgical laser instrument (Auriga XL). The "performance testing" section, as stated in the document, focuses on compliance with various ISO and IEC standards related to medical device safety, electrical safety, electromagnetic compatibility, usability, and laser safety. This is typical for a device of this nature, where the primary concern for regulatory approval is safe and effective operation within defined parameters, rather than the diagnostic accuracy of an algorithm.

Therefore, the concepts of:

A table of acceptance criteria and reported device performance (in terms of diagnostic metrics)
Sample size for test set and data provenance
Number of experts and their qualifications for ground truth
Adjudication method
Multi-reader multi-case (MRMC) comparative effectiveness study
Standalone (algorithm-only) performance
Type of ground truth (expert consensus, pathology, outcomes)
Sample size for training set
How ground truth for training set was established

...are not applicable to this type of device and submission, as it is not an AI/ML diagnostic or imaging interpretation device.

Information Extracted from the Document (related to "performance"):

1. Acceptance Criteria and Device Performance (based on standards compliance):

Acceptance Criterion (Standard Compliance)	Reported Device Performance
ISO 14971:2006 (Risk Management)	The Auriga XL is tested according to this standard. (Implies compliance, no specific performance metrics reported in this summary).
IEC 60601-1:2005 (Medical Electrical Equipment - General requirements for basic safety and essential performance)	The Auriga XL is tested according to this standard. (Implies compliance, no specific performance metrics reported).
IEC 60601-1-2:2007 (Medical Electrical Equipment - Electromagnetic compatibility)	The Auriga XL is tested according to this standard. (Implies compliance, no specific performance metrics reported).
IEC 60601-1-6:2006 (Medical Electrical Equipment - Usability) / IEC 62366:2007 (Medical Devices - Application of usability engineering to medical devices)	The Auriga XL is tested according to these standards. (Implies compliance regarding user interface and design, no specific performance metrics reported).
IEC 60601-2-22:2005 (Medical Electrical Equipment - Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment)	The Auriga XL is tested according to this standard. (Implies compliance specific to laser safety and performance for surgical lasers, no specific performance metrics reported).
IEC 60825-1:2007 (Safety of laser products - Equipment classification and requirements)	The Auriga XL is tested according to this standard. (Implies compliance with general laser product safety, no specific performance metrics reported).
IEC 62304:2006 (Medical device software - Software life cycle processes)	The Auriga XL is tested according to this standard. (Implies compliance with software development and safety for medical devices, no specific performance metrics reported).
European Medical Device 93/42/EEC + Amendment 2007/47/EC	The device also complies with this directive. (Implies overall conformity with European medical device regulations, no specific performance metrics reported).
Design Specifications	"Laboratory testing was conducted to verify and validate that the Auriga XL met all design specifications." (No specific design specifications or corresponding performance metrics are detailed in this summary).
Substantial Equivalence to Predicate Device (Lisa Laser Products - Sphinx, K033437)	"The Auriga XL is as effective and safe as the predicate device. The Auriga XL is substantially equivalent to the cited legally marked predicate device." (This is the ultimate conclusion, not a performance metric itself).

Regarding other specific questions:

2. Sample size used for the test set and the data provenance: Not applicable. The "testing" refers to compliance with engineering and safety standards, not a diagnostic test on a data set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic accuracy is not relevant here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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, as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a surgical laser, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device would be its ability to safely and effectively perform its stated functions according to engineering specifications and safety standards.
8. The sample size for the training set: Not applicable. There is no training set for an algorithm in this submission.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document focuses on regulatory compliance for a physical medical device (a surgical laser), not the performance evaluation of a diagnostic algorithm or AI system.

Summary

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K111475
1 of 4.

SEP 2 8 2011

Image /page/0/Picture/2 description: The image shows the logo for starmedtec. The logo consists of a black square with a white target symbol inside, followed by the word "starmedtec" in a sans-serif font. Below the word "starmedtec" is the phrase "innovative solutions" in a smaller font.

510(k) Auriga XL Summary (Section 5)

510(k) summary of safety and effectiveness information according 21 CFR Part 807.87(h)

1. General Information:
- a. Applicant:

StarMedTec GmbH Kreuzstrasse 22 82319 Starnberg Germany +49815126861-0 (phone) +49815126861-35 (fax)

b. Contact:
Date Prepared: C.
1. Names:
- a. Device Name:
- b. Common Name:
- Classification Name: C.
- d. Product code:

Gregor Weidemann May 20, 2011

Auriga XL
Auriga XL Laser instrument, surgical, powered GEX
1. Predicate Device:
  Lisa Laser Products - Sphinx (510(k) Number: K033437)
1. Product Description:
  The Auriga XL is a holmium laser system, which emits laser radiation with a wavelength of approximately 2.1 um. The laser power transfers an optical application fiber. The indications are lithotripsy, dissection, ablation, resection and coagulation of tissue. The laser system consists of:
laser system including control panel (user interface) -
foot switch
application fiber -
1. Indications for use:

Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectorny, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery.

Urology

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

Strictures of urethra and ureter -
Bladder Neck Incisions (BNI) -

{1}------------------------------------------------

K111475

Image /page/1/Picture/1 description: The image shows the text "510(k) Auriga XL Summary (Section 5)". The text is in bold and is black. The text is likely a title or heading for a document or section of a document.

Image /page/1/Picture/2 description: The image shows the logo for starmedtec. The logo consists of a black square with a white target symbol on the left, and the word "starmedtec" in a sans-serif font on the right. Below the word "starmedtec" is the phrase "innovative solutions" in a smaller font with a line extending from the right side of the phrase.

Ablation and resecetion of Bladder Tumors, Uretheral Tumors and Ureteral -Tumors
Ablation of Benign Prostatic Hyperplasia (BPH) -
Transurethral incision of prostate (TUIP)
Holmium Laser Resection of the prostate (HoLRP) -
Holmium Laser Enucleation of the prostate (HoLEP)
Holmium Laser Ablation of the prostate (HoLap) -
Bladder/Renal calculi (Lithotripsy) 1
Condylomas -
Lesions or external genitalia -
Lithotripsy
Percutaneous Urinary Lithtripsy -
Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones
Endoscopic fragemnation of kidney calculi -
Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed

Gastroenterology

Open and endoscopic gastroenterological surgery (incision, excision, ablation, vaporization, coagulation and hemostasis) including:

Appendectomy
Polyps
Biopsv
Gall Bladder Calculi (Lithotripsy) ー
Biliary/Bile duct calculi (Lithotripsy)
Ulcers
Gastric ulcers
Duodenal ulcers
Non bleeding ulcers ﮯ
Pancreatitis
Hemorrhoids
Cholecystectomy
Benign and malignant neoplasm
Angiodysplasia
Colorectal cancer ー
Telangiectasias
Telangiectasias of Osler-Weber-Renu disease
Vascular malformation
Gastritis
Esophagitis
Esophageal ulcers
Varices
Colitis
Mallory-Weiss tear
Gastric Erosions

{2}------------------------------------------------

KII1475
3 of 4

Image /page/2/Picture/1 description: The image shows the title "510(k) Auriga XL" in bold, followed by the subtitle "Summary (Section 5)" also in bold. The text is black and the background is white. The text appears to be part of a document or presentation.

Image /page/2/Picture/2 description: The image shows the logo for starmedtec. The logo consists of a black square with a white target symbol on the left, and the word "starmedtec" in black letters on the right. Below the word "starmedtec" is the phrase "innovative solutions" in a smaller font, with a line above and below the phrase.

Arthroscopy

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

Ligament and tendon Release -
Countouring and sculpting of articular surfaces -
Capsulectomie in the knee ﺖ
Chondreoplasty in the knee l
Debridement of inflamed synovial tissue -
Chondromalacia ablation …
Chondtromalcia and tears "
Plica removal -
Meniscectomy -
Loose body debridement ー
Lateral retineacular release -

Ablation of soft, cartilanginous and bony tissue in minimal invasive spinal surgery including

Percutaneous laser disc decompression/discectomy of the L4-5 and L5-S1 । lumbar discs, including forminoplasty
Percutaneous cervical disc decompression/discectomy -
Percutaneous thoracic disc decompression/discectomy -

Thoracic and Pulmonary

Open and endoscopic thoracic and pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue

Gynaecology

Open and endoscopic/laparoscopic gynaecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis).

ENT

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

Endonasal / sinus surgery -
Partial turbinectomy -
Polypectomy -
Dacryocystorhinostomy ー
Frontal sinustomy t
Ethmoidectomy -
Maxillary antrostomy 1
Functional endoscopic sinus surgery -

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K111475
4 of 4

510(k) Auriga XL Summary (Section 5)

Image /page/3/Picture/2 description: The image shows the logo for starmedtec. The logo consists of a black square with a white target symbol on the left, and the word "starmedtec" in black letters on the right. Below the word "starmedtec" is the phrase "innovative solutions" in a smaller font.

Dermatology and Plastic Surgery

Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue, muscosal tissue, fatty tissue and cartilaginous tissue in therapeutic plastic, dermatologic and aesthetic surgical procedures including:

Basal Cell Carcinomas -
Lesion of skin and subcutaneous tissue 1
Skin tags -
Plantar warts 1
Lesions of skin and subcutaneous tissue -
Port wine stains ー
Papillomas -

General Surgery

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

Appendectomy -
Biopsy -
Skin incision ー
ﺖ Excision of external tumours and lesions
Complete or partial resection of internal organs, turnours, lesions -
1. Performance testing:

The Auriga XL is tested according to following standards:

ISO 14971:2006 IEC 60601-1:2005 (DIN EN 60601-1:2006) IEC 60601-1-2:2007 (DIN EN 60601-1-2:2007-12) IEC 60601-1-6:2006 (DIN EN 60601-1-6:2007) / IEC 62366:2007 (DIN EN 62366:2008) IEC 60601-2-22:2005 IEC 60825-1:2007 (DIN EN 60825-1:2007) IEC 62304:2006 (DIN EN 62366:2006) The device also complies with European Medical Device 93/42/EEC + Amendment 2007/47/EC

1. Performance data
  Laboratory testing was conducted to verify and validate that the Auriga XL met all design specifications and is substantially equivalent to the predicate device. Clinical data: No clinical information is required.
1. Conclusion:
  The Auriga XL is as effective and save as the predicate device. The Auriga XL is substantially equivalent to the cited legally marked predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle faces left and is enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper part of the circle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

StarMedTec GmbH % Mr. Gregor Weidemann Kreuzstrasse 22 Starnberg, Germany 82319

SEP 2 8 2011

Re: K111475

Trade/Device Name: Auriga XL 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 21, 2011 Received: September 23, 2011

Dear Mr. Weidemann:

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.

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

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

Page 2 – Mr. Gregor Weidemann

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 (reporting of medical device-related 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 331-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutliDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Sincerely, yours,

Eunice Keith

for Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/6/Picture/1 description: The image shows the logo for starmedtec. The logo consists of a black square with a white target symbol on the left, and the word "starmedtec" in black letters on the right. Below the word "starmedtec" is the phrase "innovative solutions" in a smaller font. A horizontal line extends from the target symbol to the word "starmedtec".

Indications for Use

510(k) Number (if known): K111475

Device Name: Auriga XL

1. Indications for use:
  The Auriga XL laser system including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in medical specialities including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office o

the RP Usler for mxn
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111475

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

nnovative solutions

Urology

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

Strictures of urethra and ureter
Bladder Neck Incisions (BNI) -
Ablation and resecetion of Bladder Tumors, Uretheral Tumors and i Ureteral Tumors
Ablation of Benign Prostatic Hyperplasia (BPH) -
Transurethral incision of prostate (TUIP) -
Holmium Laser Resection of the prostate (HoLRP) -
Holmium Laser Enucleation of the prostate (HoLEP) -
Holmium Laser Ablation of the prostate (HoLap)
Bladder/Renal calculi (Lithotripsy) ー
Condylomas ー
Lesions or external genitalia -
Lithotripsy
Percutaneous Urinary Lithtripsy
Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones
Endoscopic fragemnation of kidney calculi t
Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed

× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ODE)
Neikpegh for mkn

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K114725

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

510(k) Auriga XL Indication for Use Statement (section 4)

starmedtec onovative solutions

Gastroenterology

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

Appendectomy -
Polyps -
Biopsy -
Gall Bladder Calculi (Lithotripsy) -
Biliary/Bile duct calculi (Lithotripsy) -
Ulcers -
Gastric ulcers -
Duodenal ulcers -
Non bleeding ulcers ー
Pancreatitis -
Hemorrhoids "
Cholecystectomy -
Benign and malignant neoplasm -
Angiodysplasia ー
Colorectal cancer -
Telangiectasias -
Telangiectasias of Osler-Weber-Renu disease -
Vascular malformation
Gastritis
Esophagitis
Esophageal ulcers
Varices
Colitis
Mallory-Weiss tear
Gastric Erosions

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE

Neil R.P. Dofe for man

vision Sign-Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111475

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

Image /page/9/Picture/1 description: The image shows the logo for starmedtec. The logo consists of a black square with a white circle and crosshairs inside, followed by the word "starmedtec" in black letters. Below the word "starmedtec" is the phrase "innovative solutions" in a smaller font.

Arthroscopy

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

Ligament and tendon Release -
Countouring and sculpting of articular surfaces -
Capsulectomie in the knee -
Chondreoplasty in the knee ー
Debridement of inflamed synovial tissue -
Chondromalacia ablation ー
Chondtromalcia and tears -
Plica removal -
Meniscectomy -
Loose body debridement -
Lateral retineacular release -

Ablation of soft, cartilanginous and bony tissue in minimal invasive spinal surgery including

Percutaneous laser disc decompression/discectomy of the L4-5 and L5--S1 lumbar discs, including forminoplasty
Percutaneous cervical disc decompression/discectomy -
Percutaneous thoracic disc decompression/discectomy

Thoracic and Pulmonary

Open and endoscopic thoracic and pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (OI

(ODE)
Neil R. Adler for mam

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111475

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

Image /page/10/Picture/1 description: The image shows the logo for starmedtec. The logo consists of a black square with a white target symbol on the left, and the word "starmedtec" in black letters on the right. Below the word "starmedtec" is the phrase "innovative solutions".

Gynaecology

Open and endoscopic/laparoscopic gynaecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis).

ENT

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

Endonasal / sinus surgery -
Partial turbinectomy -
Polypectomy ー
Dacryocystorhinostomy -
Frontal sinustomy -
Ethmoidectomy -
-Maxillary antrostomy
Functional endoscopic sinus surgery -

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

	Neil RP Ogden for mam
	(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number	K111475

{11}------------------------------------------------

Dermatology and Plastic Surgery

Basal Cell Carcinomas -
Lesion of skin and subcutaneous tissue -
Skin tags -
Plantar warts -
Lesions of skin and subcutaneous tissue -
Port wine stains -
Papillomas -

General Surgery

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

Appendectomy -
-Biopsy
Skin incision =
Excision of external tumours and lesions -
Complete or partial resection of internal organs, tumours, lesions -

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Evaluation code for mxm

(Division Sign-Off)

Division of Surgical, Orthopedic,

and Restorative Devices

510(k) Number	K111475
---------------	---------

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.