PLANCON MIRCOLAMELLAR KERATOME

K960395 · Plancon Instruments · HNO · Apr 26, 1996 · Ophthalmic

Device Facts

• Record ID: K960395
• Device Name: PLANCON MIRCOLAMELLAR KERATOME
• Applicant: Plancon Instruments
• Product Code: HNO · Ophthalmic
• Decision Date: Apr 26, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4370
• Device Class: Class 1
• 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.

Indications for Use

Indicated for patients requiring micro lamellar keratoplasty for the correction of myopia or hyperopia.

Regulatory Classification

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)

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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 |

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K960395
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# 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 |