(192 days)
Not Found
No
The document describes a laser system for ophthalmic surgery and does not mention any AI or ML components.
No
The device is described as a surgical laser used in refractive surgery, specifically for creating corneal cuts/flaps, which is an active intervention to modify tissue, not a therapeutic treatment itself.
No
Explanation: The device is described as an ophthalmic surgical laser used for creating corneal cuts and resections in patients undergoing eye surgery, not for diagnosing conditions.
No
The device description explicitly states it is a "stationary scanning-spot femtosecond laser system," indicating it is a hardware device.
Based on the provided information, the WaveLight® FS200 Laser System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The WaveLight® FS200 Laser System is a surgical laser used to perform cuts and resections directly on the cornea of a patient's eye. It is a therapeutic device used in vivo (within the living body) during surgery, not a diagnostic test performed in vitro (outside the living body) on a sample.
- Intended Use: The intended uses clearly describe surgical procedures on the cornea.
- Device Description: The description confirms it's a surgical laser system.
Therefore, the WaveLight® FS200 Laser System falls under the category of a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The WaveLight® FS200 Laser System is an ophthalmic surgical laser indicated for use:
- · In the creation of a corneal flap in patients undergoing LASIK surgery or other surgery or treatment requiring initial lamellar resection of the cornea.
- · In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments.
- · In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty.
- · In the creation of a penetrating cut/incision for penetrating keratoplasty and for corneal harvesting.
Product codes
GEX, HNO
Device Description
The WaveLight® FS200 Laser System is a stationary scanning-spot femtosecond laser system used in refractive surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cornea
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)
Performance tests according to the FDA Guidance "Keratome and Replacement Keratome Blades Premarket Notification [(510(k)] Submissions'' were conducted to collect data on the accuracy, precision and quality of the cuts achieved with the WaveLight® FS200 Laser System .
The WaveLight® FS200 Laser System and the accessory Patient Interface were found to perform equivalently to the predicate laser and microkeratome and their patient interfaces for the creation of corneal cuts.
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
WaveLight® FS200 Laser System
OCT 2 1 2010
K10joo6
5. 510(K) SUMMARY
510(k) Summary
This summary document is being prepared in accordance with section 21 CFR 807.92(c).
The submitter of the 510(k) is:
Michael Buenger Associate Director, Regulatory Affairs Alcon Research, Ltd. 6201 South Freeway Fort Worth, TX 76134 Phone: (817) 551-6810 Fax: (817) 551-4630
Date Summary Revised: September 30, 2010
Device Subject to this 510(k):
WaveLight® FS200 Laser System Trade Name: Common Name: Laser Powered Laser Surgical Instrument Classification Name:
1. Predicate Devices:
The legally marketed device(s) to which we are claiming substantial equivalence are:
| 510(k) Number | Device |
|---|---|
| K060372 | FS Laser System |
| K032910 | Carriazo Pendular Keratom |
| K073404 | iFS Laser System |
2. Device Description:
The WaveLight® FS200 Laser System is a stationary scanning-spot femtosecond laser system used in refractive surgery.
1
WaveLight® FS200 Laser System
3. Indications for Use:
Indications for Use:
The WaveLight® FS200 Laser System is an ophthalmic surgical laser indicated for use:
- · In the creation of a corneal flap in patients undergoing LASIK surgery or other surgery or treatment requiring initial lamellar resection of the cornea.
- · In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments.
- · In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty.
- · In the creation of a penetrating cut/incision for penetrating keratoplasty and for corneal harvesting.
4. Statement of how the Technological Characteristics of the Device compare to those of the Predicate or legally marketed Device
The technological characteristics of the WaveLight® FS200 Laser System are very similar to those of the predicate laser devices. The WaveLight® FS200 Laser System and the predicate laser devices are femtosecond lasers which work in the same mode at similar frequencies with similar spot sizes. The WaveLight® FS200 Laser System works at a slightly higher pulse repetition rate and shorter pulse duration. The WaveLight® FS200 Laser System and the predicate laser devices use similar common materials and the same energy source. Therefore, the technological characteristics of the WaveLight® FS200 Laser System are substantially equivalent those of the predicate laser devices cleared under K060372 and K073404. The technological characteristics of the WaveLight® FS200 Laser System and the Carriazo Pendular Keratome (K032910) are different in that the predicate device is a mechanical keratome. The Carriazo Pendular Keratome was used as a predicate device for the purpose of flap cutting comparison. The WaveLight® FS200 is considered as an alternative to mechanical microkeratomes.
2
WaveLight® FS200 Laser System
5. Brief Summary of Nonclinical Test and Results:
The WaveLight® FS200 Laser System has undergone testing and is in compliance with the applicable safety standards.
Performance tests according to the FDA Guidance "Keratome and Replacement Keratome Blades Premarket Notification [(510(k)] Submissions'' were conducted to collect data on the accuracy, precision and quality of the cuts achieved with the WaveLight® FS200 Laser System .
The WaveLight® FS200 Laser System and the accessory Patient Interface were found to perform equivalently to the predicate laser and microkeratome and their patient interfaces for the creation of corneal cuts.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized symbol resembling three human figures connected at the arms, positioned to the right. Encircling this symbol is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Alcon Research, Ltd. c/o Mr. Michael Buenger Associate Director, Regulatory Affairs 6201 South Freeway Forth Worth, TX 76134
OCT 2 1 2010
Re: K101006
Trade/Device Name: WaveLight® FS200 Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Powered Laser Surgical Instrument Regulatory Class: Class II Product Code: GEX, HNO Dated: October 1, 2010 Received: October 6, 2010
Dear Mr. Buenger:
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.
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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/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 yours,
Kasia Alexander
Image /page/4/Picture/7 description: The image shows a handwritten word "for" in cursive, positioned to the left of three lines of text. The text on the right consists of the letters "M", "D", and "O", each followed by a colon. The text is vertically aligned, with the word "for" appearing to be an annotation or label associated with the text on the right.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
KIDIOOG OCT 2-1-2010
WaveLight® FS200 Laser System
4. INDICATIONS FOR USE STATEMENT
510(k) Number: K101006
WaveLight® FS200 Laser System Device Name:
Indications for Use:
The WaveLight® FS200 Laser System is an ophthalmic surgical laser indicated for use:
- · In the creation of a corneal flap in patients undergoing LASIK surgery or other surgery or treatment requiring initial lamellar resection of the cornea.
- · In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments.
- · In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty.
- · In the creation of a penetrating cut/incision for penetrating keratoplasty and for corneal harvesting.
X Prescription Use _ AND/OR (Part 21 CFR 801 Subpart D)
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)
Dr. Callan
Page 16 Of 1890
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear,
Nose and Throat Devices
510(k) Number K101006
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