← Product Code [HNO](/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO) · K970377 # PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES) (K970377) _Plancon Instruments · HNO · Mar 31, 1997 · Ophthalmic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K970377 ## Device Facts - **Applicant:** Plancon Instruments - **Product Code:** [HNO](/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO.md) - **Decision Date:** Mar 31, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 886.4370 - **Device Class:** Class 1 - **Review Panel:** Ophthalmic - **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. ## 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 - PLANCON INSTRUMENTS Microlamellar Keratome ([K960395](/device/K960395.md)) - EYE TECHNOLOGY (Not known) - SCMD ([K935342](/device/K935342.md)) ## 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} 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 | --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K970377](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K970377) **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