(86 days)
Not Found
No
The description focuses on the hardware and basic control electronics of a laser system, with no mention of AI or ML capabilities. The microprocessor is described as performing basic system monitoring and control functions, not complex data analysis or learning.
Yes
The device is described as being used for various surgical procedures and treatments for medical conditions, which aligns with the definition of a therapeutic device.
No
The device description and intended use indicate that the OcuLight TX is a surgical laser used for treatment procedures (e.g., stapedectomy, retinal photocoagulation, treatment of skin lesions), not for diagnosis.
No
The device description clearly states it is a "solid state laser" and includes hardware components such as a laser console, optical fiber delivery devices, and a footswitch. It is not solely software.
Based on the provided information, the OcuLight TX is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes surgical procedures performed directly on the patient's body (otolaryngological, dermatological, and ophthalmic). IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the body to provide information about a person's health.
- Device Description: The description details a laser system designed to deliver light for surgical applications. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological specimens.
- Providing diagnostic information based on laboratory tests.
- Reagents or consumables for sample processing.
The OcuLight TX is a therapeutic device used for surgical interventions, not a diagnostic device used for testing samples.
N/A
Intended Use / Indications for Use
The OcuLight TX is intended for use in otolaryngological, dermatological and ophthalmic surgical procedures. In otolaryngology it is indicated for stapedectomy, stapedotomy, myringotomy, lysis of adhesions, control of bleeding, removal of acoustic neuromas, and soft tissue adhesion in micro/macro otologic procedures. In dermatology it is indicated for the treatment of vascular and pigmented skin lesions. In ophthalmology it is indicated for retinal photocoagulation, laser trabeculoplasty, iridotomy, and iridoplasty.
Otolaryngology:
The OcuLight TX is intended to be used in ENT surgery for tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis. Indications for use include, but are not limited to:
Stapedectomy, Stapedotomy
Myringotomy
Lysis of adhesions
Control of Bleeding
Removal of Acoustic Neuromas
Soft Tissue Adhesion in Micro/Macro Otologic Procedures
Dermatology:
The OcuLight TX is intended to photocoagulate issue in dermatological procedures. Indications for use include:
Focal laser treatment of vascular and pigmented skin lesions.
Ophthamology:
The OcuLight TX is intended to photocoagulate ocular tissue in ophthalmic procedures. Indications for use include:
Retinal Photocoagulation
Laser Trabeculoplasty
Iridotomy
Iridoplasty
Prescription Use (Part 21 CFR 801 Subpart D)
Product codes
GEX
Device Description
The OcuLight TX is a solid state laser that delivers true continuous wave green laser (532 nm) light for otolaryngologic, dermatology, and ophthalmic applications. The integrated system is comprised of the OcuLight TX laser console, various compatible optical fiber delivery devices, and a Footswitch. The laser console contains the laser head, imaging optics, power supplies, control electronics, and firmware. The electronic system is comprised of various sense and control electronics, user controls and displays, and an embedded microprocessor that monitors all system functions. The microprocessor interprets operator commands, formats displays and supervises laser emission. A visible red (630-650 nm) semiconductor diode laser is used for aiming.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Otolaryngological, dermatological, ophthalmic
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)
Not Found
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.
K050562, K022327, K032220, K002296
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
§ 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
2369
Section 5-510(k) Summary or 510(k) Statement
I. General Information
Contact Person:
Submitter:
IRIDEX Corporation 1212 Terra Bella Avenue Mountain View, CA 94043-1824 USA
John Jossy Director of Regulatory Affairs and Quality Assurance
Summary Preparation Date: August 11, 2006
II. Names
Device Names:
OcuLight TX
Primary Classification Names: Laser Powered Surgical Instrument; Laser, Ophthalmic
III. Predicate Devices
- IRIS Medical OcuLight GL/GLx (K050562) .
- . Leminis Inc. Novus Spectra (K022327)
- Adept Medical Concepts, Inc Quanta (K032220) .
- . Biolitec AG (K002296)
IV. Product Description
The OcuLight TX is a solid state laser that delivers true continuous wave green laser (532 nm) light for otolaryngologic, dermatology, and ophthalmic applications. The integrated system is comprised of the OcuLight TX laser console, various compatible optical fiber delivery devices, and a Footswitch. The laser console contains the laser head, imaging optics, power supplies, control electronics, and firmware. The electronic system is comprised of various sense and control electronics, user controls and displays, and an embedded microprocessor that monitors all system functions. The microprocessor interprets operator commands, formats displays and supervises laser emission. A visible red (630-650 nm) semiconductor diode laser is used for aiming.
V. Indications for Use
The OcuLight TX is intended for use in otolaryngological, dermatological and ophthalmic surgical procedures. In otolaryngology it is indicated for stapedectomy, stapedotomy, myringotomy, lysis of adhesions, control of bleeding, removal of acoustic neuromas, and soft tissue adhesion in micro/macro otologic procedures. In dermatology it is indicated for the treatment of vascular and pigmented skin lesions. In ophthalmology it is indicated for retinal photocoagulation, laser trabeculoplasty, iridotomy, and iridoplasty.
1
Rationale for Substantial Equivalence VI.
The OcuLight TX shares the same or similar indications for use, device operation, overall the Oculergit 12x shares the same ies and therefore is substantially equivalent to the predicate devices.
Safety and Effectiveness Information VII.
The review of the indications for use and technical characteristics provided demonstrates that the OcuLight TX is substantially equivalent to the predicate devices.
VIII. Conclusion
The OcuLight TX was found to be substantially equivalent to the predicate devices.
The OcuLight TX shares the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to, the 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 features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 8 2006
IRIDEX Corporation % Mr. John Jossy Director, Regulatory Affairs and Quality Assurance 1212 Terra Bella Avenue Mountain View, California 94043-1824
Rc: K062369 Trade/Device Name: OcuLight TX 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: October 11, 2006 Received: October 13, 2006
Dear Mr. Jossy:
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 cnclosure) 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, listing 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 III (PMA), it 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 complics 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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
3
Page 2 - Mr. John Jossy
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. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| Indications for Use Statement |
|---|
| ------------------------------- |
| 510(k) Number (if known): | K062369 |
|---|---|
| --------------------------- | --------- |
Device Name: OcuLight TX
Otolaryngology:
The OcuLight TX is intended to be used in ENT surgery for tissue incision, excision, The Oculation, vaporization, ablation and vessel hemostasis. Indications for use include, but are not limited to:
Stapedectomy, Stapedotomy Myringotomy Lysis of adhesions Control of Bleeding Removal of Acoustic Neuromas Soft Tissue Adhesion in Micro/Macro Otologic Procedures
Dermatology:
The OcuLight TX is intended to photocoagulate issue in dermatological procedures. Indications for use include:
Focal laser treatment of vascular and pigmented skin lesions.
Ophthamology:
The OcuLight TX is intended to photocoagulate ocular tissue in ophthalmic procedures. Indications for use include:
Retinal Photocoagulation Laser Trabeculoplasty Iridotomy Iridoplasty
Prescription Use (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)
(Division Sign-6 Division of General, Restorative,
and Neurological Devices
510(k) Number
K06256
Page 1 of 1