(25 days)
Not Found
No
The document describes a laser delivery system integrated into a slit lamp, focusing on optical and mechanical components. There is no mention of AI, ML, image processing, or any data-driven decision-making capabilities.
Yes
The device is described as an "ophthalmic laser delivery system" used to "diagnose and treat ocular disease," indicating it has a direct therapeutic function.
Yes
The "Intended Use / Indications for Use" section explicitly states "The Lumenis 1000 Integrated Slit Lamp laser delivery system is indicated for a variety of ophthalmic diagnostic and treatment uses".
No
The device description explicitly lists multiple hardware components, including a slit lamp, laser delivery telescope, micromanipulator, eye safety filter, and an electrically adjustable table.
Based on the provided information, the Lumenis 1000 Integrated Slit Lamp laser delivery 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 description clearly states that the Lumenis 1000 Integrated Slit Lamp is a laser delivery system integrated into a slit lamp for ophthalmic diagnostic and treatment uses. It is used to deliver laser energy directly to the eye for treatment and to aid in diagnosis through visualization.
- No Sample Analysis: There is no mention of the device analyzing any samples taken from the body. Its function is to interact directly with the eye.
Therefore, the Lumenis 1000 Integrated Slit Lamp falls under the category of a medical device used for direct patient examination and treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K022181, K022327, K000498, K990174, K022327, K981952
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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KOSZI29
AUG 3 0 2005
Attachment 8 510(k) Summary Statement
General Information I.
| Submitter: | Lumenis, Inc.
2400 Condensa Street
Santa 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 Panel
GEX, 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.
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.
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.
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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 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. |
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