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
Indications for 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.
{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.: (33-1) 46 74 46 74
| | 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 |
