PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES)

K970377 · Plancon Instruments · HNO · Mar 31, 1997 · Ophthalmic

Device Facts

• Record ID: K970377
• Device Name: PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES)
• Applicant: Plancon Instruments
• Product Code: HNO · Ophthalmic
• Decision Date: Mar 31, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4370
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

To perform microlamellar keratoplasty for the correction of myopia or hyperopia

Device Story

The Plancon Instruments Microlamellar Keratome is a surgical instrument used by ophthalmologists to perform microlamellar keratoplasty. The system consists of a gas-powered turbine motor, a fixed single-piece keratome head, a keratome blade, pneumatic fixation rings, and applanation lenses. The device is powered by a vacuum pump unit that regulates gas pressure. During surgery, the pneumatic fixation ring secures the eye, and the keratome head, equipped with a blade, creates a lamellar corneal incision. The fixed-head design limits the cut depth to a single predetermined value, enhancing safety compared to adjustable-head models. The device is used in a clinical or surgical setting to facilitate refractive surgery, potentially improving patient vision by correcting myopia or hyperopia.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System includes gas-powered turbine motor (0-20,000 RPM), stainless steel/titanium/aluminum construction, pneumatic fixation rings, and applanation lenses. Operates via gas pressure regulation. Fixed single-piece keratome head design. No gear system.

Indications for Use

Indicated for patients requiring microlamellar 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

• PLANCON INSTRUMENTS Microlamellar Keratome (K960395)
• EYE TECHNOLOGY (Not known)
• SCMD (K935342)

Submission Summary (Full Text)

{0}

MAR 31 1997
K970377

# SAFETY AND EFFECTIVENESS SUMMARY K970377 p. 1/2

Plancon Instruments, 15 Rue Georges Besse, 92160 Antony, France
Contact person: Mr. Alain DUPRAT, General Manager
Date: December 13, 1996
Tel.: [phone]

| | Predicated device ①
510 K Document number
K 960395 | Predicated device ②
510 document number :
Not known | Predicated device ③
510 K document number :
K 935342 | Submitted device |
| --- | --- | --- | --- | --- |
| Designation / Feature | PLANCON INSTRUMENTS
Microlamellar Keratome | EYE TECHNOLOGY | SCMD | PLANCON INSTRUMENTS
Microlamellar Keratome
(single piece head) |
| Intended use | To perform microlamellar 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 | To perform microlamellar 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
Turbine motor
Fixed keratome head
Keratome blade
Pneumatic fixation rings
Applanation lenses |
| 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 | Vacuum pump
Battery
Vacuum release valve
Knob to regulate gas pressure
Gas & vacuum pressure gauges
Vacuum & turbine quick connectors
Battery charger unit |

{1}

K970377

SAFETY AND EFFECTIVENESS SUMMARY K970377 p. 2/2

| | Predicated device ①
510 K Document number
K 960395 | Predicated device ②
510 document number :
Not known | Predicated device ③
510 K document number :
K 935342 | Submitted device |
| --- | --- | --- | --- | --- |
| Designation / Feature | PLANCON INSTRUMENTS
Microlamellar Keratome | EYE TECHNOLOGY | SCMD | PLANCON INSTRUMENTS
Microlamellar Keratome
(single piece head) |
| 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 | Gas powered
Adjustable speed 0 to 20 000 RPM (recommended 14 000 RPM)
Material : stainless steel, titanium and aluminium.
No gear system |
| Keratome | Material : stainless steel
Adjustable
Safety : maximum cut depth, and checking gauge | Material : stainless steel
Adjustable
Permanent adjustable head with adjustment knob
Safety : maximum cut depth and checking gauge | Material : stainless steel
Adjustable
Safety : maximum cut depth and checking gauge | Material : stainless steel
Fixed single piece head
Safety : only one cut depth allowed by head principle |
| Pneumatic fixation rings | Material : stainless steel
Double dovetails | 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 : clear plastic + stainless handle
Engraved inner reticle diameter | Material : clear plastic + stainless handle
Engraved inner reticle diameter | Material : clear plastic + stainless handle
Engraved inner reticle diameter |