(81 days)
Not Found
No
The device description focuses on the laser's physical parameters and user control, with no mention of AI or ML for image processing, decision support, or automated functions.
Yes
The device is intended to reduce intraocular pressure, which is a therapeutic intervention.
No
The device description states it is a laser system intended for performing laser trabeculoplasty, which is a treatment procedure. It does not mention any function for diagnosing conditions or diseases.
No
The device description clearly outlines a hardware system including a flashlamp-pumped laser, optical fiber, and footswitch, which are physical components, not software.
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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The SOLX 790 Titanium Sapphire system is a laser used for surgical treatment (laser trabeculoplasty) performed directly on the eye. It delivers energy to the trabecular meshwork to reduce intraocular pressure.
- No Sample Analysis: The device does not analyze any biological samples taken from the patient. It is a therapeutic device used for a medical procedure.
Therefore, the description clearly indicates a therapeutic laser device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Laser trabeculoplasty to reduce intraocular pressure in patients with poorly controlled intraocular pressure on maximally tolerated medical therapy or prior failed laser trabeculoplasty
Product codes (comma separated list FDA assigned to the subject device)
HQF, GEX
Device Description
The SOLX 790 Titanium Sapphire system is a flashlamp-pumped laser intended for use in performing laser trabeculoplasty. The laser operates at a wavelength of 790 nanometers (nm), and delivers user-selectable pulse energies of 30-80 millijoules (mJ), with nominal pulse duration of 8 microseconds (7+2usec) and a nominal spot size of 200 microns (um). A footswitch activates the laser to deliver pulses of laser energy through an optical fiber to a slit lamp. A trained physician then directs the laser pulses exiting the slit lamp to the desired regions of the trabecular meshwork inside the eye using a Goldman goniolens. A low power, visible aiming beam allows the physician to direct the treatment laser pulses.
The laser is comprised of the following functional components:
- Electronics Module .
- Laser Optical Head
- Control Panel .
- Slit Lamp/Slit Lamp Table ●
- Covered Footswitch .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Trabecular meshwork inside the eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physician
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)
Preclinical and clinical data was provided to demonstrate that the Titanium Sapphire is safe and effective for use in trabeculoplasty to reduce intraocular pressure in patients with poorly controlled or elevated intraocular pressure or prior failed laser trabeculoplasty.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 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
Revised August 11, 2008
SEP 1 2 2008
510(k) Summary of safety and effectiveness
| APPLICANT | SOLX, Inc. |
|---|---|
| TRADE NAME: | SOLX 790 Titanium Sapphire Laser |
| COMMON NAME: | Ophthalmic Laser |
| CLASSIFICATION NAME: | Ophthalmic lasers for use in laser trabeculoplasty |
| DEVICE CLASSIFICATION: | Class II |
| PRODUCT CODE | CFR 886.4390 Product code HQF (laser, ophthalmic) and |
| CFR 878.4810 Product code GEX (laser surgical | |
| instrument). | |
| PREDICATE DEVICE: | ULTIMA 2000 ARGON LASER K913127 |
USER FEE PAYMENT ID:
SUBSTANTIALLY EQUIVALENT TO:
| COHERENT (LUMENIS) | Ultima 2000 Argon Laser | K913127 |
|---|---|---|
| -------------------- | ------------------------- | --------- |
The SOLX 790 Titanium Sapphire Laser is substantially equivalent in intended of action to the Coherent/Lumenis Ultima 2000 Argon Laser approved under K913127.
5.1 DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The SOLX 790 Titanium Sapphire system is a flashlamp-pumped laser intended for use in performing laser trabeculoplasty. The laser operates at a wavelength of 790 nanometers (nm), and delivers user-selectable pulse energies of 30-80 millijoules (mJ), with nominal pulse duration of 8 microseconds (7+2usec) and a nominal spot size of 200 microns (um). A footswitch activates the laser to deliver pulses of laser energy through an optical fiber to a slit lamp. A trained physician then directs the laser pulses exiting the slit lamp to the desired regions of the trabecular meshwork inside the eye using a Goldman goniolens. A low power, visible aiming beam allows the physician to direct the treatment laser pulses.
PRODUCT INFORMATION
The laser is comprised of the following functional components:
- Electronics Module .
- Laser Optical Head
- Control Panel .
- Slit Lamp/Slit Lamp Table ●
- Covered Footswitch .
1
Table A Comparison of SOLX 790 Titanium Sapphire Laser and Predicate Device
| SOLX | Coherent Ultima 2000 | |
|---|---|---|
| 790 Titanium | Argon Ophthalmic Laser | |
| Sapphire | K913127 | |
| Ophthalmic Laser | ||
| Indications for Use | Laser trabeculoplasty to | |
| reduce intraocular pressure in | ||
| patients with poorly | ||
| controlled intraocular | ||
| pressure on maximally | ||
| tolerated medical therapy or | ||
| prior failed laser | ||
| trabeculoplasty | *Indicated for use in the | |
| treatment of ocular | ||
| pathology including | ||
| trabeculoplasty in open- | ||
| angle glaucoma | ||
| Clinical Treatment | ||
| Power/Energy | 30-80mJ | 50-1750 mW |
| Pulse duration | 7±2 microseconds | 0.01-1.0 sec |
| Laser Media | Titanium Sapphire | Argon |
| Wavelength | 790 nm ± 5 nm | *488/514 nm (blue-green) |
| Mode of Operation | pulsed | CW |
| Spot Size | 200 um | *50-1000 µm |
| Aiming Beam | Diode, variable | |
| intensity to |