The Lumenis 1000 Integrated Slit Lamp laser delivery system is indicated for a variety of ophthalmic diagnostic and treatment uses including, but not limited to, the indications specified in the compatible laser's Operator Manuals. The Lumenis 1000 Integrated Slit Lamp may be used in the medical specialties or procedures that have been given market clearance by the Food and Drug Administration through the compatible laser systems. The Lumenis 1000 Integrated Slit Lamp is compatible with Lumenis lasers only.

Device Description

The Lumenis 1000 Integrated Slit Lamp consists of an ophthalmic laser delivery system and an associated eye safety filter that has been integrated into a conventional slit lamp to provide the most efficient means to diagnose and treat ocular disease. The Lumenis 1000 Integrated Slit Lamp consists of: (1) a slit lamp with parallel binocular optics and fiveposition magnification, (2) SureSpot™ 1000 um laser delivery telescope, (3) laser aiming and treatment beam micromanipulator (4) an internal three-color ClearView™ laser eye safety filter, and (5) an electrically adjustable table with slit lamp power supply, elbow rest, laser mounting tray, and laser power outlets.

AI/ML Overview

This 510(k) premarket notification for the "Lumenis 1000 Integrated Slit Lamp" does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria through performance metrics. Instead, it focuses on demonstrating substantial equivalence to predicate devices, which is a different regulatory pathway.

Here's an analysis based on the provided document:

Table of Acceptance Criteria and Reported Device Performance:
The document does not specify any quantitative acceptance criteria or report specific performance metrics for the Lumenis 1000 Integrated Slit Lamp. The basis for substantial equivalence is "the same indications for use, similar technologies, and functional features" as the predicate devices.

Acceptance Criteria	Reported Device Performance
Not specified	Not specified

Sample Size Used for the Test Set and Data Provenance:
No test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective) is mentioned, as a performance study demonstrating device efficacy or safety against specific criteria was not conducted for this 510(k). The regulatory submission relies on substantial equivalence.
Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. The submission does not involve a study with a test set requiring expert-established ground truth.
Adjudication Method:
Not applicable. No expert adjudication process is described.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was performed. The document does not describe any human-in-the-loop performance evaluation or an assessment of how human readers improve with or without AI assistance, as the device is a laser delivery system integrated into a slit lamp, not an AI diagnostic tool.
Standalone (Algorithm Only) Performance Study:
No standalone performance study was conducted. The device is a physical medical instrument (laser delivery system) and not an algorithm or AI.
Type of Ground Truth Used:
Not applicable. The submission does not refer to ground truth data as it's not a study evaluating diagnostic accuracy or a similar performance characteristic.
Sample Size for the Training Set:
Not applicable. This device is a hardware product, not a machine learning model, so there is no concept of a "training set."
How Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.

Summary of the K052129 Submission:

The K052129 submission for the Lumenis 1000 Integrated Slit Lamp is a 510(k) substantial equivalence submission. This regulatory pathway does not typically require new clinical studies or detailed performance data against specific acceptance criteria if the device can be shown to be substantially equivalent to a legally marketed predicate device.

The rationale for substantial equivalence is based on the device sharing:

"the same indications for use"
"similar technologies"
"functional features"

The document explicitly states: "There have been no significant changes or modifications from the predicate devices that affect the safety or effectiveness of the Lumenis 1000 Integrated Slit Lamp." This indicates that the safety and efficacy are largely presumed to be similar to the predicate devices (Lumenis (Coherent) LaserLink Z-1000 Slit Lamp Laser Delivery Adapter [K022181, K022327, K000498] and Lumenis (HGM) M140 Integrated Slit Lamp [K990174, K022327, K981952]).

Summary

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

KOSZI29

AUG 3 0 2005

Attachment 8 510(k) Summary Statement

General Information I.

Submitter:	Lumenis, Inc.2400 Condensa StreetSanta Clara, California, U. S. A.95051-0901
Contact Persons:	Karen L. Baker
Summary Preparation Date:	August 24, 2005
Names
Device Names:	Lumenis 1000 Integrated Slit Lamp
Primary Classification Name:	79, General and Plastic Surgery PanelGEX, Laser powered surgical instrument

III. Predicate Devices

II.

Lumenis (Coherent) LaserLink Z-1000 Slit Lamp Laser Delivery Adapter [K022181, K022327, K000498] Lumenis (HGM) M140 Integrated Slit Lamp (K990174, K022327, K981952)

Product Description IV.

V. Indications for Use

The Lumenis 1000 Integrated Slit Lamp laser delivery system is indicated for a variety of The Damemic diagnostic and treatment uses including, but not limited to, the indications specified in the compatible laser's Operator Manuals. The Lumenis 1000 Integrated Slit Specifical in the medical specialties or procedures that have been given market clearance by the Food and Drug Administration through the compatible laser systems. The Lumenis 1000 Integrated Slit Lamp is compatible with Lumenis lasers only.

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

K05.2129 2 of 2

Rationale for Substantial Equivalence VI.

The Lumenis 1000 Integrated Slit Lamp shares the same indications for use, similar The Balleries, and finctional features and is therefore substantially equivalent to the legally marketed predicate devices.

Safety and Effectiveness Information VII.

The specifications and intended uses of the Lumenis 1000 Integrated Slit Lamp is the same or similar to that for the claimed predicate devices. There have been no significant changes or modifications from the predicate devices that affect the safety or effectiveness of the Lumenis 1000 Integrated Slit Lamp.

The determination of substantial equivalence was based upon the comparison of the technical characteristics between the Lumenis 1000 Integrated Slit Lamp and the predicate laser systems.

VIII. Conclusion

The Lumenis 1000 Integrated Slit Lamp is substantially equivalent to similar predicate devices.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right.

AUG 3 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Karen L. Baker Manager, Regulatory Affairs Lumenis, Inc. 2400 Condensa Street Santa Clara, California 95051

Re: K052129 Trade/Device Name: Lumenis 1000 Integrated Slit Lamp Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: August 3, 2005 Received: August 5, 2005

Dear Ms. Baker:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon > 10(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the cherosure) to regars and ment date of the Medical Device Amendments, or to commerce pror to May 20, 1978, in easily 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). and Costietle Hot (110.) that to nevice, subject to the general controls provisions of the Act. The I ou may, therefore, thanks the act include requirements for annual registration, listing of general controls provisioning practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is elasbilion (600 a00 rols. Existing major regulations affecting your device can may be subject to back access and Regulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Cour acements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I least of advised that I Dr o locally syour device complies with other requirements of the Act that I Dri has made a actuations administered by other Federal agencies. You must or any I coolar bakates and submitted to: registration and limited to: registration and listing (21 Comply with an the Here Prequent Bart 801); good manufacturing practice requirements as set CI K I art 007), adoning (21 CFR Part 820); and if applicable, the electronic forth in the quality byovens (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2- Ms. Karen L. Baker

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter witi anow you to oegin maining of substantial equivalence of your device to a legally premarket notication. The PDF intelligention for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific acriously at (240) 276-0115. Also, please note the regulation entitled, Comaci the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Barbara Bouchemp

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known):	K052129
Device Name:	Lumenis 1000 Integrated Slit Lamp
Indications For Use:	The Lumenis 1000 Integrated Slit Lamp laser deliverysystem is indicated for a variety of ophthalmic diagnosticand treatment uses including, but not limited to, theindications specified in the compatible laser's OperatorManuals. The Lumenis 1000 Integrated Slit Lamp may beused in the medical specialties or procedures that havebeen given market clearance by the Food and DrugAdministration through the compatible laser systems. TheLumenis 1000 Integrated Slit Lamp is compatible withLumenis lasers only.

510(k) Number (if known):

K052129

Device Name:

Lumenis 1000 Integrated Slit Lamp

Indications For Use:

The Lumenis 1000 Integrated Slit Lamp laser deliverysystem is indicated for a variety of ophthalmic diagnosticand treatment uses including, but not limited to, theindications specified in the compatible laser's OperatorManuals. The Lumenis 1000 Integrated Slit Lamp may beused in the medical specialties or procedures that havebeen given market clearance by the Food and DrugAdministration through the compatible laser systems. TheLumenis 1000 Integrated Slit Lamp is compatible withLumenis lasers only.

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

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

barbare buelnd

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

Page 1 of

510(k) Number K052129

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.