← Product Code [HNO](/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO) · K960395

# PLANCON MIRCOLAMELLAR KERATOME (K960395)

_Plancon Instruments · HNO · Apr 26, 1996 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K960395

## Device Facts

- **Applicant:** Plancon Instruments
- **Product Code:** [HNO](/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO.md)
- **Decision Date:** Apr 26, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.4370
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic
- **Attributes:** Therapeutic

## Intended Use

To perform micro lamellar keratoplasty for the correction of myopia or hyperopia

## Device Story

Plancon Instruments micro lamellar keratoplasty system; used for refractive surgery (myopia/hyperopia correction). System components: gas-powered turbine motor (0-20,000 RPM), adjustable keratome head, stainless steel keratome blade, pneumatic fixation rings, applanation lenses, and vacuum power unit. Operated by ophthalmologists in clinical/surgical settings. Device creates corneal lamellar cuts; surgeon uses applanation lenses and fixation rings to stabilize eye; turbine motor drives keratome blade to perform resection. Output is precise corneal tissue resection; facilitates refractive correction. Benefits include surgical precision in lamellar keratoplasty procedures.

## Clinical Evidence

Bench testing only. No clinical data provided.

## Technological Characteristics

Materials: stainless steel, titanium, aluminum. Energy source: gas-powered turbine motor (0-20,000 RPM). Components: vacuum pump, pneumatic fixation rings, applanation lenses with engraved reticles. Mechanical operation; no gear system. No software or electronic control systems described.

## Regulatory Identification

A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.

## Predicate Devices

- Predicated device 1 (not specified)
- Predicated device 2 (not specified)

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

200

APR 26 1996

K960395

# SAFETY AND EFFECTIVENESS SUMMARY

|  Designation / Feature | Submitted device
PLANCON INSTRUMENTS | Predicated device ① | Predicated device ②  |
| --- | --- | --- | --- |
|  Intended use | To perform micro lamellar keratoplasty for the correction of myopia or hyperopia | To perform micro lamellar keratoplasty for the correction of myopia or hyperopia | To perform micro lamellar keratoplasty for the correction of myopia or hyperopia  |
|  System composition | Power unit
Turbine motor
Adjustable keratome head
Keratome blade
Pneumatic fixation rings
Applanation lenses
Plate checking gauge | Power unit
Turbine motor
Adjustable keratome head
Keratome blade
Pneumatic fixation rings
Applanation lenses
Plate checking gauge | Power unit
Turbine motor
Adjustable keratome head
Keratome blade
Pneumatic fixation rings
Applanation lenses
Plate checking gauge  |
|  Power unit | Vacuum pump
Battery
Vacuum release valve
Knob to regulate gas pressure
Gas & vacuum pressure gauges
Vacuum & turbine quick connectors
Battery charger unit | Vacuum pump
Battery
Vacuum release valve
Knob to regulate gas pressure
Gas & vacuum pressure gauges
Vacuum & turbine quick connectors
Battery charger unit | Vacuum pump
Battery
Vacuum release valve
Knob to regulate gas pressure
Gas & vacuum pressure gauges
Vacuum & turbine quick connectors
Battery charger unit  |

{1}

K960395
Page 2/2

# SAFETY AND EFFECTIVENESS SUMMARY

|   | PLANCON INSTRUMENTS | PREDICATED DEVICE 1 | PREDICATED DEVICE 2  |
| --- | --- | --- | --- |
|  Turbine motor | Gas powered
Adjustable speed 0 to 20 000 RPM
(recommended 14 000 RPM)
Material: stainless steel, titanium,
and aluminium.
No gear system | Gas powered
Adjustable speed
Material: stainless steel
No gear system | Gas powered
Adjustable speed from 10 to 24 000 RPM
Pre-set speed 14 000 RPM
Material: stainless steel and brass
No gear system  |
|  Keratome | Material: stainless steel
Adjustable
Safety: maximum cut depth, and
checking gauge | Material: stainless steel
Adjustable
Permanent adjustable head with
adjustment kno
Safety:
- maximum cut depth and checking
gauge | Material: stainless steel
Adjustable
Safety:
- maximum cut depth and checking gauge  |
|  Pneumatic fixation rings | Material: stainless steel
Double dovetails | Material: stainless steel
Double dovetails | Material: stainless steel
Double dovetails  |
|  Applanation lenses | Material: clear plastic + stainless
handle
Engraved inner reticle diameter | Material: c ear plastic + stainless
handle
Engraved inner reticle diameter | Material: clear plastic + stainless handle
Engraved inner reticle diameter  |

---

**Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K960395](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K960395)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com