K Number

Device Name

CERALAS DIODE LASER SYSTEM (CERALAS D2)

Manufacturer

CERAMOPTEC, INC.

Date Cleared

1997-02-21

(87 days)

Product Code

HQF

Regulation Number

886.4390

Intended Use

photocoagulation of ocular tissue. The Oculight SLx is intended to be used to perform retinal photocoagulation as well as anterior segment procedures. The Keeler Microlase SL is intended for use in ophthalmic photocoagulation and is specifically indicated for use in the treatment of glaucoma and all retinal vascular diseases. The Nidek DC3000 is promoted as an ophthalmic photocoagulator. The Ceralas D2 and its predicates are all intended for the photocoagulation of ocular tissue which includes the retina as well as the anterior segment.

Device Description

The Ceralas D2 is a complete self-contained compact surgical laser that utilizes gallium aluminum arsenide ("GaAlAs") semiconductor diodes to generate near-infrared laser radiation. The laser employs a modular design comprised of: (1) a laser diode and cooling module containing the laser diode; (2) an optics module containing a beamsplitter pickoff for automatic control of total optical power; (3) front control and display panels; and (4) RFI-shielded, transformer isolated power supplies and control electronics. A fiber optic delivery system is coupled to the laser via an SMA-905 connector to deliver laser radiation to the target tissues. The fiber optic delivery system available with the Ceralas D2 consists of fibers with 200 um diameters. The Ceralas D2, like the predicate devices, is a microprocessor controlled, solid state laser that can be operated with slit lamps, indirect ophthalmoscopes, and endocular probes. The lasers all use diodes to create a laser treatment beam. The Ceralas D2 emits a beam between 780 and 840 nm, nominally at 810 nm; the Keeler Microlase SL emits light between 780 and 840 nm; and the Oculight SLx emits light nominally around 810 nm. The Ceralas D2, the Oculight SLx, and the Nidek DC3000 all have maximum laser treatment beam powers of 2 watts. The laser treatment beam emitted by the Ceralas D2 and the predicates can be delivered continuously or in pulses. The Ceralas D2's pulse can be varied from 0.1 to 99.9 seconds, i.e., to an effectively continuous delivery mode. The Oculight SLx has pulses of up to a 9 second duration. The pulse duration for the Keeler Microlase SL ranges between 0.01 and 1 second.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the hardware components and basic microprocessor control for laser parameters, with no mention of AI or ML algorithms for image analysis, treatment planning, or automated control beyond simple power and pulse duration adjustments.

Therapeutic

Yes
The device is described as a "complete self-contained compact surgical laser" intended for "photocoagulation of ocular tissue... in the treatment of glaucoma and all retinal vascular diseases," indicating its use for therapeutic procedures.

Diagnostic

No
Explanation: The device is described as a "complete self-contained compact surgical laser" used for "photocoagulation of ocular tissue," which is a treatment procedure, not a diagnostic one.

SaMD (Software as a Medical Device)

The device description clearly details hardware components such as laser diodes, optics modules, control panels, power supplies, and a fiber optic delivery system. While it mentions microprocessor control, it is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "photocoagulation of ocular tissue." This is a therapeutic procedure performed directly on a patient's body.
Device Description: The device is a surgical laser designed to deliver laser radiation to target tissues within the eye. This is a treatment device, not a diagnostic one.
Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide diagnostic information about a patient's condition.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device performs a therapeutic action (photocoagulation) directly on the patient.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Ceralas D2 and the predicates have the same intended use; photocoagulation of ocular tissue. The Oculight SLx is intended to be used to perform retinal photocoagulation as well as anterior segment procedures. The Keeler Microlase SL is intended for use in ophthalmic photocoagulation and is specifically indicated for use in the treatment of glaucoma and all retinal vascular diseases. The Nidek DC3000 is promoted as an ophthalmic photocoagulator. The Ceralas D2 and its predicates are all intended for the photocoagulation of ocular tissue which includes the retina as well as the anterior segment.

Product codes

Not Found

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

ocular tissue which includes the retina as well as the anterior segment

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.

Not Found

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

Not Found

Regulation Number and Section

§ 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.

Summary

FEB 2 1 1997

FOR CERAMOPTEC INC.'S CERALAS DIODE LASER SYSTEM (MODEL D2)

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Jonathan S. Kahan, Esq. Hogan & Hartson L.L.P. 555 13th Street, N.W. Washington, D.C. 20004-1109 Phone: (202) 637-5794 Facsimile: (202) 637-5910

as Regulatory Counsel to CeramOptec, Inc.

Contact Person: same as above

Date Prepared: November 25, 1996

Name of Device and Name/Address of Sponsor

Ceralas Diode Laser System (Model D2)

CeramOptec, Inc. 515 Shaker Road East Longmeadow, MA 01028

Classification Name

Ophthalmic laser

Common or Usual Name

Diode Laser

Proprietary Name

Ceralas Diode Laser System (includes the Ceralas D2 laser and accessories) ("Ceralas D2")

Predicate Devices

Iris Medical Oculight SLx (1)
Keeler Microlase SL (2)
(3) Nidek DC3000

Intended Use

\\DC - 61213/1 - 0370374.01

The Keeler Microlase SL is intended for use in ophthalmic photocoagulation and is specifically indicated for use in the treatment of glaucoma and all retinal vascular diseases. The Nidek DC3000 is promoted as an ophthalmic photocoagulator. The Ceralas D2 and its predicates are all intended for the photocoagulation of ocular tissue which includes the retina as well as the anterior segment.

Technological Characteristics and Substantial Equivalence

The Ceralas D2 is substantially equivalent to the predicate devices because they have the same intended use, principles of operation and technological characteristics. The Ceralas D2, like the predicate devices, is a microprocessor controlled, solid state laser that can be operated with slit lamps, indirect ophthalmoscopes, and endocular probes. The lasers all use diodes to create a laser treatment beam. The Ceralas D2 emits a beam between 780 and 840 nm, nominally at 810 nm; the Keeler Microlase SL emits light between 780 and 840 nm; and the Oculight SLx emits light nominally around 810 nm. The Ceralas D2, the Oculight SLx, and the Nidek DC3000 all have maximum laser treatment beam powers of 2 watts.

The laser treatment beam emitted by the Ceralas D2 and the predicates can be delivered continuously or in pulses. The Ceralas D2's pulse can be varied from 0.1 to 99.9 seconds, i.e., to an effectively continuous delivery mode. The Oculight SLx has pulses of up to a 9 second duration. The pulse duration for the Keeler Microlase SL ranges between 0.01 and 1 second. Although there are differences between the pulse duration of the Ceralas D2 and the predicates, this difference does not raise any new issues of safety or effectiveness because the predicate lasers operate in both continuous and pulsed delivery modes and the Ceralas D2 merely provides pulse durations incrementing from 0.1 seconds to what is effectively a continuous delivery mode.