Who is the manufacturer of CPC PROBE?

Carl Zeiss, Inc. filed the 510(k) submission for CPC PROBE (K961380).

What is the FDA product code for CPC PROBE?

GEX. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for CPC PROBE?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like CPC PROBE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CPC PROBE

Q: What are the predicate devices for CPC PROBE?

Iris Medical G-Probe (K915236).

K961380 · Carl Zeiss, Inc. · GEX · Mar 17, 1997 · General, Plastic Surgery

Device Facts

Record ID	K961380
Device Name	CPC PROBE
Applicant	Carl Zeiss, Inc.
Product Code	GEX · General, Plastic Surgery
Decision Date	Mar 17, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Zeiss CPC Probe is a laser delivery system designed for use with the Visulas Diode II laser from Carl Zeiss. When used in tandem they form an ophthalmic laser treatment device. The CPC Probe is used to reduce the intraocular pressure associated with the eye disease Glaucoma.

Device Story

Laser delivery system; used with Visulas Diode II laser; ophthalmic therapeutic application. Probe applied to sclera 1.5 mm behind limbus; delivers laser impulses to photocoagulate ciliary body. Physician-operated in clinical setting. Reduces intraocular pressure; slows glaucoma progression. Output: laser energy delivery. Benefit: intraocular pressure reduction.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological design and intended use.

Technological Characteristics

Laser delivery probe; fiber-optic based; designed for contact application to sclera. Materials differ from predicate. Sterilizable tip. Energy source: external diode laser (Visulas Diode II).

Indications for Use

Indicated for patients diagnosed with Glaucoma to reduce intraocular pressure via photocoagulation of the ciliary body.

Regulatory Classification

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.

Predicate Devices

Iris Medical G-Probe (K915236)

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K143154 — IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID) · Iridex Corporation · Jan 2, 2015
K032357 — NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES · Lumenis, Inc. · Oct 9, 2003
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Submission Summary (Full Text)

{0} K961390 # 510-k Summary MAR 17 1997 Pursuant to 21 CFR 807.92 the following summary is submitted. 1. Submitter's name- Carl Zeiss, Inc. 1 Zeiss Drive Thornwood, NY 10594 (914) 681-7761 Contact Person-Kenneth M. Nicoll April 4, 1996 2. Zeiss CPC Probe Laser Probe 3. We are claiming substantial equivalence to the Iris Medical G-Probe, K 915236. 4. The Zeiss CPC Probe is a laser delivery system designed for use with the Visulas Diode II laser from Carl Zeiss. When used in tandem they form an ophthalmic laser treatment device. The CPC Probe is used to reduce the intraocular pressure associated with the eye disease Glaucoma. The contact probe is applied with slight pressure to the sclera and located approximately 1.5 mm behind the limbus. This method significantly increases the transmission of the sclera and also reduces the scattering of the laser beam. The power is adjusted and increased successively until the proper effect is heard. The power is then reduced and remaining coagulations can be performed if needed. 5. This device will be used in the same manner as the device mentioned above and will permit the Zeiss Visulas Diode II to be further utilized as a therapeutic ophthalmic laser. It incorporates the same intended uses as the Iris Medical G Probe and specifically is recommended for treating the following eye disease: Glaucoma. 6. The Zeiss CPC Probe is substantially equivalent to the Iris Medical G Probe in that both are used to permit the individual companies laser to deliver impulses that photocoagulate the ciliary body of the eye in patients that are diagnosed with Glaucoma, thereby reducing the patient's intraocular pressure which slows the progress of the disease. The only differences between the two delivery units are: The approximate amount of times the contact tips can be sterilized, the material the tips are made of and slight differences in the power range.