K Number
K962592
Device Name
OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR, OR EQUIVALENT LASER SYSTEMS
Manufacturer
Date Cleared
1996-09-23

(83 days)

Product Code
Regulation Number
878.4810
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ophthalas 532 laser is intended to be used in all clinical applications for which an Argon laser would be used in ophthalmic surgery, including, but not limited to Retinal and Macular Photocoagulation: Transcleral Cyclophotocoagulation: Internal Sclerostomy; Iridotomy; and Trabeculoplasty.
Device Description
The Ophthalas 532 Solid State Photocoagulator, and/or equivalent devices, are a pulsed solid state frequency doubled Nd:YAG laser producing a characteristic 532 nanometer (nm) wavelength light as the therapeutic beam. A 633 nm helium-neon (HeNe) laser is used for the aiming beam source.
More Information

Ophthalas® 532 Photocoagulator, blue-green Argon Ophthalmic Lasers

Not Found

No
The summary describes a laser device for ophthalmic surgery and does not mention any AI or ML components or functionalities.

Yes
The device is described as a "photocoagulator" and its intended uses include various ophthalmic surgical procedures like "Retinal and Macular Photocoagulation," implying direct treatment of a medical condition. The device also "produces a characteristic 532 nanometer (nm) wavelength light as the therapeutic beam," further indicating its therapeutic purpose.

No

Explanation: The device is a therapeutic laser used for ophthalmic surgery (photocoagulation, sclerostomy, iridotomy, trabeculoplasty), not for diagnosis. It produces a therapeutic beam (532 nm) and an aiming beam (633 nm), neither of which are described as being used for diagnostic purposes.

No

The device description clearly states it is a "Solid State Photocoagulator" and describes hardware components like a Nd:YAG laser and a helium-neon laser, indicating it is a hardware device.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body ("in vitro").
  • Ophthalas 532 Function: The Ophthalas 532 laser is a therapeutic device that uses light energy to treat conditions within the eye. It directly interacts with the patient's tissue inside the body ("in vivo").
  • Lack of Specimen Analysis: The description doesn't mention any analysis of biological specimens. Its purpose is to deliver a therapeutic laser beam.

Therefore, based on the provided information, the Ophthalas 532 laser is a therapeutic ophthalmic device, not an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

The Ophthalas 532 laser is intended to be used in all clinical applications for which an Argon laser would be used in ophthalmic surgery, including, but not limited to Retinal and Macular Photocoagulation: Transcleral Cyclophotocoagulation: Internal Sclerostomy; Iridotomy; and Trabeculoplasty.

Product codes

Not Found

Device Description

The Ophthalas 532 Solid State Photocoagulator, and/or equivalent devices, are a pulsed solid state frequency doubled Nd:YAG laser producing a characteristic 532 nanometer (nm) wavelength light as the therapeutic beam. A 633 nm helium-neon (HeNe) laser is used for the aiming beam source.

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

The Ophthalas 532 Laser consistently and safely produces a thermal lesion equivalent to those produced by conventional Argon lasers.

Key Metrics

Not Found

Predicate Device(s)

Ophthalas® 532 Photocoagulator, blue-green Argon Ophthalmic Lasers

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.

0

SEP 23 1988

K962592

Image /page/0/Picture/2 description: The image shows the logo and contact information for Alcon Laboratories, Inc. The logo is a stylized, bold typeface. Below the logo is the company name, address, and phone number. The address is 6201 South Freeway, Fort Worth, TX 76134, and the phone number is (817) 551-8388.

May 14, 1996

510(K) SUMMARY

.....

Submitted by:

Martin A. Kaufman Manager, Regulatory Affairs, Surgical Devices Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76132 (817) 551-8388 (Phone) (817) 551-4630 (Fax)

Trade Name: Ophthalas® 532 Solid State Photocoagulator Common Name: Solid state ophthalmic laser photocoagulator Classification Name: Ophthalmic Laser (per 21 CFR 886.4390)

1

1. Predicate Device

The legally marketed device(s) to which we are claiming equivalence to are the Ophthalas® 532 Photocoagulator marketed by Alcon Laboratories, and blue-green Argon Ophthalmic Lasers cleared for the Trabeculoplasty indication.

2. Device Description

The Ophthalas 532 Solid State Photocoagulator, and/or equivalent devices, are a pulsed solid state frequency doubled Nd:YAG laser producing a characteristic 532 nanometer (nm) wavelength light as the therapeutic beam. A 633 nm helium-neon (HeNe) laser is used for the aiming beam source.

3. Intended Use of the Device

The Ophthalas 532 laser is intended to be used in all clinical applications for which an Argon laser would be used in ophthalmic surgery, including, but not limited to Retinal and Macular Photocoagulation: Transcleral Cyclophotocoagulation: Internal Sclerostomy; Iridotomy; and Trabeculoplasty.

4. Summary of the Technological Characteristics of the Device

The Ophthalas 532 is a Neodymium-doped Yttrium Aluminum Garnet type laser which has been designed for ophthalmic use. LASER is an acronym for "Light Amplified by Stimulated Emission of Radiation." This laser delivers a 532 nm green laser beam (frequency doubled), a 633 nm HeNe (Helium-Neon) aiming beam, and a 1064 nm infrared laser beam.

The laser beam may be defined as a visible (i.e.; green 532 nm) or invisible (i.e.; 1064 nm), coherent monochromatic light beam.

The doubling process of the 1064 wavelength results when the infrared beam goes through a special crystal. The crystal is an optical dielectric that exhibits a non-linear optical response. The 532nm wavelength is produced by harmonic generation of the 1064nm laser beam.

5. Summary of the Performance Data

The Ophthalas 532 Laser consistently and safely produces a thermal lesion equivalent to those produced by conventional Argon lasers.

6. Conclusions

The Ophthalas 532 Laser is substantially equivalent to Argon lasers for the treatment of all clinical applications for which an Argon laser would be used in ophthalmic surgery, including, but not limited to Retinal and Macular Photocoagulation; Transcleral Cyclophotocoagulation; Internal Sclerostomy; Iridotomy; and Trabeculoplasty.

$\rightarrow$