(27 days)
Not Found
No
The device description focuses on the laser technology and optical components, with no mention of AI or ML for image processing, diagnosis, or treatment planning.
Yes
The device is described as an ophthalmic surgical laser system intended for the "treatment of ocular pathology" and states several therapeutic procedures such as "photodisruption of ocular tissue," "discission of the posterior capsule of the eye (posterior capsulotomy)," "discission of pupillary membranes (pupillary membranectomy)," "iridotomy/iridectomy," and "selective laser trabeculoplasty." These are all therapeutic interventions designed to treat medical conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the Selecta 1064, Selecta SLT and Selecta Duet Ophthalmic Lasers are "also intended for use as a diagnostic slit lamp," and it is "used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior segment."
No
The device description clearly states it is a "fully integrated flash lamp pumped, solid state, Nd:YAG ophthalmic surgical laser system" and describes various hardware components like lasers, optics, and delivery systems. This is a hardware device with integrated software for control and operation, not a software-only medical device.
Based on the provided information, this device 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 described device is a surgical laser system used for treating ocular tissue through photodisruption and selective laser trabeculoplasty. It also functions as a diagnostic slit lamp for examining the anterior segment of the eye.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It directly interacts with and treats tissue within the body.
- Diagnostic Function: While it has a diagnostic function as a slit lamp, this is a direct examination of the eye's structure, not an analysis of a biological sample.
Therefore, the primary function and intended use of this device fall under the category of a surgical and diagnostic medical device used in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- photodisruption of ocular tissue using light energy emitted by a Nd:YAG Selecta 1064: laser, including discission of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy/iridectomy
- selective laser trabeculoplasty Selecta SLT:
- photodisruption of ocular tissue using light energy emitted by a Nd:YAG Selecta Duet: laser, including discission of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy/iridectomy; and
selective laser trabeculoplasty - laser delivery system for use by an ophthalmologist in the treatment of LaserLink S: ocular tissue;
laser delivery system indicated for use for a variety of ophthalmic uses, including the indications specified in the laser operator manual. Refer to the laser operator manual, Indications for Use section.
The Selecta 1064, Selecta SLT and Selecta Duet Ophthalmic Lasers are also intended for use as a diagnostic slit lamp, specifically,
An AC-powered slit lamp biomicroscope intended for use in eye examination of the anterior segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior segment.
- same indications for use as a Selecta 1064 and LaserLink S slit lamp Selecta Duo: device with a currently cleared Lumenis 532nm photocoagulator
- Selecta Trio: same indications for use as a Selecta Duet and LaserLink S slit lamp delivery device with a currently cleared Lumenis 532nm photocoagulator
Product codes
GEX
Device Description
The Lumenis Selecta is a fully integrated flash lamp pumped, solid state, Nd:YAG ophthalmic surgical laser system intended for use in the treatment of ocular pathology and for use as a diagnostic slit lamp.
The Selecta Family of Ophthalmic Lasers, Delivery Device and Accessories are comprised of the following configurations:
Selecta 1064 - a Nd:YAG laser providing Q-switched laser pulses at a wavelength of 1064nm for use in photodisruption of ocular tissue (posterior capsulotomy, papillary membranectomy, iridotomy). The 1064nm treatment beam delivers a 4 nsec, 0.3-10mJ adjustable and selectable single, double or triple pulse of energy. It is conditioned through beam shaping optics to generate a photodisruption micro pulse of plasma at a precision location relative to the visual focal plane (located at slit lamp center of adjustable rotation) and along the slit lamp objective lens axis. A twin aiming beam is also focused by the slit lamp objective to a converging 20um spot located at the focal point of the lens. The focal point of photodisruption is adjustable 0-350μm in the posterior direction by the physician relative to this convergence of the twin aiming beams.
Selecta SLT® - a Nd:YAG laser providing Q-switched frequency doubled pulses at a wavelength of 532nm for use in selective laser trabeculoplasty. The treatment beam delivers a 4nsec, 0.1-2mJ adjustable single pulse of energy. The aiming and treatment beams are coaxial with each other and focused by the slit lamp objective to a 400um spot at the focal point of the lens.
Selecta Duet® - a Nd:YAG laser providing Q-switched laser pulses at a wavelength of 1064 nanometers for use in photodisruption or Q-switched frequency doubled pulses at a wavelength of 532nm for use in selective laser trabeculoplasty, depending upon the mode selected. The Selecta Duo contains two aiming beam modules that produce a single beam for the 532nm mode and a dual beam for the 1064nm mode, respectively.
LaserLink S - a laser slit lamp delivery adaptor that may be coupled to each of the above Selecta models and connected to a currently cleared Lumenis 532nm photocoagulator to allow the physician to use the Selecta slit lamp to deliver 532nm continuous wave laser energy for photocoagulation.
Selecta Duo - a Selecta 1064® and LaserLink S slit lamp delivery device with a currently cleared Lumenis 532nm photocoagulator
Selecta Trio - a Selecta Duet and LaserLink S slit lamp delivery device with a currently cleared Lumenis 532nm photocoagulator
Selecta SLT and LaserLink S with a currently cleared Lumenis 532nm photocoagulator
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ocular tissue, eye, anterior segment, cornea epithelium, posterior capsule
Indicated Patient Age Range
Not Found
Intended User / Care Setting
ophthalmologist
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)
Not Found
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
Attachment 4 510(k) Summary Statement
I. General Information
Submitter:
Lumenis, Inc. 2400 Condensa Street Santa Clara, California, U. S. A. 95051-0901
Connie Hoy Contact Persons:
Summary Preparation Date: February 5, 2006
II. Names
| Device Names: | Family of Selecta Ophthalmic Laser Systems, Delivery Device and Accessories
Selecta 1064 Ophthalmic Laser System
Selecta SLT Ophthalmic Laser System
Selecta Duo Ophthalmic Laser System
Selecta Duet Ophthalmic Laser System
Selecta Trio Ophthalmic laser System
LaserLink S |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Classification Name: | 79, General and Plastic Surgery Panel
GEX, Laser powered surgical instrument |
III. Predicate Devices
- Lumenis Family of Selecta Ophthalmic Laser Systems K051944 .
IV. Product Description
The Lumenis Selecta is a fully integrated flash lamp pumped, solid state, Nd:YAG ophthalmic surgical laser system intended for use in the treatment of ocular pathology and for use as a diagnostic slit lamp.
The Selecta Family of Ophthalmic Lasers, Delivery Device and Accessories are comprised of the following configurations:
Selecta 1064 - a Nd:YAG laser providing Q-switched laser pulses at a wavelength of 1064nm for use in photodisruption of ocular tissue (posterior capsulotomy, papillary membranectomy, iridotomy). The 1064nm treatment beam delivers a 4 nsec, 0.3-10mJ adjustable and selectable single, double or triple pulse of energy. It is conditioned through beam shaping optics to generate a photodisruption micro pulse of plasma at a precision location relative to the visual focal plane (located at slit lamp center of adjustable rotation) and along the slit lamp objective lens axis. A twin aiming beam is also focused by the slit lamp objective to a converging 20um spot located at the focal point of the lens. The
1
focal point of photodisruption is adjustable 0-350μm in the posterior direction by the physician relative to this convergence of the twin aiming beams.
Selecta SLT® - a Nd:YAG laser providing Q-switched frequency doubled pulses at a wavelength of 532nm for use in selective laser trabeculoplasty. The treatment beam delivers a 4nsec, 0.1-2mJ adjustable single pulse of energy. The aiming and treatment beams are coaxial with each other and focused by the slit lamp objective to a 400um spot at the focal point of the lens.
Selecta Duet® - a Nd:YAG laser providing Q-switched laser pulses at a wavelength of 1064 nanometers for use in photodisruption or Q-switched frequency doubled pulses at a wavelength of 532nm for use in selective laser trabeculoplasty, depending upon the mode selected. The Selecta Duo contains two aiming beam modules that produce a single beam for the 532nm mode and a dual beam for the 1064nm mode, respectively.
LaserLink S - a laser slit lamp delivery adaptor that may be coupled to each of the above Selecta models and connected to a currently cleared Lumenis 532nm photocoagulator to allow the physician to use the Selecta slit lamp to deliver 532nm continuous wave laser energy for photocoagulation.
Selecta Duo - a Selecta 1064® and LaserLink S slit lamp delivery device with a currently cleared Lumenis 532nm photocoagulator
Selecta Trio - a Selecta Duet and LaserLink S slit lamp delivery device with a currently cleared Lumenis 532nm photocoagulator
Selecta SLT and LaserLink S with a currently cleared Lumenis 532nm photocoagulator
Indications for Use V.
- photodisruption of ocular tissue using light energy emitted by a Nd:YAG Selecta 1064: laser, including discission of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy/iridectomy
- selective laser trabeculoplasty Selecta SLT:
- photodisruption of ocular tissue using light energy emitted by a Nd: Y AG Selecta Duet: laser, including discission of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy/iridectomy; and
selective laser trabeculoplasty
- laser delivery system for use by an ophthalmologist in the treatment of LaserLink S: ocular tissue;
laser delivery system indicated for use for a variety of ophthalmic uses, including the indications specified in the laser operator manual. Refer to the laser operator manual, Indications for Use section.
2
The Selecta 1064, Selecta SLT and Selecta Duet Ophthalmic Lasers are also intended for use as a diagnostic slit lamp, specifically,
An AC-powered slit lamp biomicroscope intended for use in eye examination of the anterior segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior segment.
- same indications for use as a Selecta 1064 and LaserLink S slit lamp Selecta Duo: device with a currently cleared Lumenis delivery 532nm photocoagulator
- same indications for use as a Selecta Duet and LaserLink S slit lamp Selecta Trio: delivery device with a a currently cleared Lumenis 532nm photocoagulator
VI. Rationale for Substantial Equivalence
The devices in this submission are identical to the predicate devices. The purpose of this 510(K) is for a name change only with no changes to the device or the indications for use.
VII. Performance Data
None
VIII. Conclusion
The Family of Selecta Ophthalmic Laser Systems, Delivery Device and Accessories are substantially equivalent to the predicate laser devices, delivery systems and accessories. The Family of Selecta Ophthalmic Laser Systems, Delivery Device and Accessories share the same intended use, indications for use, and technological characteristics as the predicate laser systems.
3
Image /page/3/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 words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right. The eagle is composed of three curved lines that suggest the feathers of its wings and body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 9 2006
Lumenis, Inc. c/o Ms. Connie Hoy Global Director of Regulatory Affairs and Quality Assurance 2400 Condensa Street Santa Clara, California 95051
Re: K060338
Trade/Device Name: Family of Selecta Laser Systems (Selecta 1064, and Selecta Duct, Selecta Duo, Selecta Trio and Delivery Device (LaserLink S) and Accessories
Regulation Number: 21 CFR 878.4810
Regulation Name: Laser surgical instrument for use in general and plastic surgers and m dermatology
Regulatory Class: II Product Code: GEX Dated: February 5, 2006 Received: February 10, 2006
Dear Ms. Hoy:
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. Insting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class HI (PM . . may be subject to such 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
4
Page 2 - Ms. Hoy
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if annlicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmaldsmamain.html
Sincerely yours.
Q.mll
fo
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Attachment 2 Indications for Use Statement as Requested by FDA
510(K) Number (if Known):
Device Name: Family of Selecta Ophthalmic Laser Systems (Selecta SLT, Selecta 1064, and Selecta Duet, Selecta Duo, Selecta Trio and Delivery Device (LaserLink S) and Accessories ﻌﺠﺐ
Indications for Use:
photodisruption of ocular tissue using light energy emitted by a Nd: Y AG Selecta 1064: laser, including discission of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy/iridectomy
- selective laser trabeculoplasty Selecta SLT:
- photodisruption of ocular tissue using light energy emitted by a Nd: Y AG Selecta Duet: laser, including discission of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy/iridectomy; and
selective laser trabeculoplasty
- laser delivery system for use by an ophthalmologist in the treatment of LaserLink S: ocular tissue;
laser delivery system indicated for use for a variety of ophthalmic uses, including the indications specified in the laser operator manual. Refer to the laser operator manual, Indications for Use section.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Office of Device Evaluation (ODE) Concurrence o (Division Sign-Off) Division of General, Restorative, and Neurological Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________
Prescription Use: (Per 21 CFR 801.109) Optional Format 1-2-96 OR
Over-The-Counter Use:
6
Attachment 2, Continued Indications for Use Statement as Requested by FDA
510(K) Number (if Known):
Device Name: Family of Selecta Ophthalmic Laser Systems (Selecta SLT, Selecta 1064, and Selecta Duet, Selecta Duo, Selecta Trio) and Delivery Device (LaserLink S) and Accessories
Indications for Use:
The Selecta 1064, Selecta SLT and Selecta Duet Ophthalmic Lasers are also intended for use as a diagnostic slit lamp, specifically,
An AC-powered slit lamp biomicroscope intended for use in eye examination of the anterior segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior segment.
- same indications for use as a Selecta 10648 and LaserLink S slit lamp Selecta Duo: delivery device with a currently cleared Lumenis 532nm photocoagulator
- Selecta Trio: same indications for use as a Selecta Duet and LaserLink S slit lamp delivery device with a currently cleared Lumenis 532nm photocoagulator
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Of Division of General, Restorative. and Neurological Devices
K060338 510(k) Number_
Prescription Use:_ X ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------
OR
Over-The-Counter Use:_________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109) Optional Format 1-2-96