Not Found
No
The summary describes image processing and analysis for positioning and mitigating eye movement, but does not mention or imply the use of AI or ML algorithms.
Yes
The device is intended for use in patients undergoing cataract surgery for the removal of the crystalline lens and for creating incisions in the cornea, which are therapeutic procedures aimed at treating a medical condition.
No
The LENSAR Laser System - fs 3D is described as an ophthalmic surgical laser system used for creating cuts/incisions and performing phacofragmentation during cataract surgery. While it includes a biometric system for imaging and measuring the eye to guide these surgical actions, its primary function is therapeutic/surgical intervention, not diagnosis of a medical condition.
No
The device is a laser system with hardware components (laser, beam guidance system, patient interface device, biometric system) that perform the intended use. While software is mentioned as being modified, the core functionality relies on physical hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for performing surgical procedures (anterior capsulotomy, laser phacofragmentation, corneal incisions) on a patient during cataract surgery. This is a direct intervention on the human body.
- Device Description: The device is a surgical laser system designed to deliver laser pulses to the eye for therapeutic purposes. While it uses imaging for guidance, its primary function is to perform a physical action on the patient's tissue.
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease. This device does not perform any of these functions. It operates on the patient, not on a specimen from the patient.
The imaging and analysis performed by the device are for guiding the surgical procedure, not for diagnosing a condition from a sample.
N/A
Intended Use / Indications for Use
The LENSAR Laser System - fs 3D (LLS-fs 3D) is intended for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, laser phacofragmentation, and the creation of full and partial thickness single-plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.
Product codes
OOE, HOF
Device Description
The predicate LENSAR Laser System is an ophthalmic surgical laser that has been cleared by the Agency for use in anterior capsulotomy and laser phaco fragmentation in cataract surgery performed individually or consecutively during the same surgery under K120214 (LENSAR Laser System - fs 3D). In K122829, the laser expands the Indication for Use to single-plane and multi-plane clear corneal cuts/incisions. This expansion of the Indication for Use is for partial as well as full thickness single-plane and multi-plane arc cuts/incisions in the cornea.
The current LLS-fs 3D uses the same laser and the same beam guidance system to deliver laser pulses to the eye as the predicate LENSAR device cleared via 510(k) K120214 and K 122829. Also, the patient interface device (PID), controlled force docking mechanism and moveable optical head to dock the laser to the stationary patient are unchanged from that 510(k) K120214 and K122829.
The LLS-fs 3D biometric system, which measures and constructs a three dimensional model of the optical surfaces within the eye, is unchanged from the predicate device except for software modifications to allow the system to analyze the shape and position of the peripheral cornea. To improve the accuracy of incision placement in the cornea, a new functionality called "Localized Imaging" has been added to the system. Localized Imaging is a process whereby the biometric camera is positioned to observe the corneal incision site and a very small laser mark (at low energy) is made at the center of the stroma. By imaging and measuring the position of the mark relative to the cornea anterior and posterior surfaces, the system mitigates any potential of incorrect laser beam placement due to eve movement. The corneal incision surgery is performed immediately after Localized Imaging and results in accurate incision depth in the cornea (85um.
Key Metrics
- Accuracy of incision depth (85um)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.
0
510(K) SUMMARY
MAR 2 7 2013
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92(a).
SUBMITTER'S NAME. ADDRESS, TELEPHONE NUMBER, CONTACT PERSON, AND DATE SUMMARY PREPARED
a. Applicant:
D
LENSAR, Inc. 2800 Discovery Drive, Suite 100 Orlando, FL 32826 Tel: (888) 536-7271 Fax: (407) 386-7228
b. Contact Person:
S.K. McGarvey Regulatory Consultant skmcgg@aol.com Cell: (702) 524-3701 Fax: (407) 386-7228
DATE SUMMARY PREPARED: December 12, 2012
NAME OF DEVICE, INCLUDING TRADE NAME AND CLASSIFICATION NAME
- LENSAR Laser System fs 3D (LLS-fs 3D) a. Trade/Proprietary Name:
- b. Common/Usual Name: LENSAR Laser System - fs 3D (LLS-fs 3D)
- Ophthalmic Laser, Phacofragmentation System C. Classification Name:
- 21 CFR 886.4390 OOE; 21 CFR 886.4670 HOC d. Classification Code(s):
PREDICATE DEVICES
| 510(K) # | TRADE NAME | MANUFACTURER |
|---|---|---|
| K122829 | LENSAR Laser System - fs 3D | LENSAR, Inc. |
| K120214 | LENSAR Laser System - fs 3D | LENSAR, Inc. |
| K101626 | LenSx 550 Laser System | LenSx Lasers, Inc. (Alcon) |
DEVICE DESCRIPTION
The predicate LENSAR Laser System is an ophthalmic surgical laser that has been cleared by the Agency for use in anterior capsulotomy and laser phaco fragmentation in cataract surgery performed individually or consecutively during the same surgery under K120214 (LENSAR Laser System - fs 3D). In K122829, the laser expands the Indication for Use to single-plane and multi-plane clear corneal cuts/incisions. This expansion of the
1
Indication for Use is for partial as well as full thickness single-plane and multi-plane arc cuts/incisions in the cornea.
The current LLS-fs 3D uses the same laser and the same beam guidance system to deliver laser pulses to the eye as the predicate LENSAR device cleared via 510(k) K120214 and K 122829. Also, the patient interface device (PID), controlled force docking mechanism and moveable optical head to dock the laser to the stationary patient are unchanged from that 510(k) K120214 and K122829.
The LLS-fs 3D biometric system, which measures and constructs a three dimensional model of the optical surfaces within the eye, is unchanged from the predicate device except for software modifications to allow the system to analyze the shape and position of the peripheral cornea. To improve the accuracy of incision placement in the cornea, a new functionality called "Localized Imaging" has been added to the system. Localized Imaging is a process whereby the biometric camera is positioned to observe the corneal incision site and a very small laser mark (at low energy) is made at the center of the stroma. By imaging and measuring the position of the mark relative to the cornea anterior and posterior surfaces, the system mitigates any potential of incorrect laser beam placement due to eve movement. The corneal incision surgery is performed immediately after Localized Imaging and results in accurate incision depth in the cornea (85um.
- The addition of partial thickness arc cuts/incisions did not result in additional . hazards although the probabilities and severities of some of the hazards identified for the predicate device were changed.
Based on the above supportive documentation, the LENSAR Laser System - fs 3D with modified software to permit partial thickness corneal arc cuts/incisions in cataract surgery is substantially equivalent to the LENSAR Laser for anterior capsulotomy and cataract fragmentation (K120214), and full thickness single-plane and multi-plane clear corneal incisions (K122829) with respect to technological characteristics, and to the LenSx Laser (K101626) for the indication for use in corneal arc cuts/incisions.
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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 consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
March 27, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
LensAR, Inc. % Ms. S.K. McGarvey Regulatory Consultant 2800 Discovery Drive, Suite 100 Orlando, FL 32826
Re: K123859
Trade/Device Name: Lensar Laser System- fs 3D (LLS-fs 3D) Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Femtosecond Laser Regulatory Class: Class II Product Code: OOE, HOF Dated: February 8, 2013 Received: February 14, 2013
Dear Ms. McGarvey:
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. Iisting 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 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
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Page 2 - Ms. S.K. McGarvey
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 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/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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia YAlexander -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K123859
Device Name: LENSAR Laser System - fs 3D (LLS-fs 3D)
Indications For Use:
The LENSAR Laser System - fs 3D (LLS-fs 3D) is intended for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, laser phacofragmentation, and the creation of full and partial thickness single-plane and multi-plane arc cuts/ incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.
Prescription Use الااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااا (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)
Leonid Livshitz 2013.03.21 16:50:40-04'00'
(Division Sign-Off) Division of Ophthalmic and Ear, Nose, and Throat Devices 510(k) Number: K 123859
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