Description
FDA has developedthis guidance documentto assist industry in preparing premarket notification submissions for keratomes and replacement keratome blades. The device is intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant. Keratomes, originally used during cornea transplant surgery, are now widely used during the laser refractive surgical procedure known as laser-assisted in situ keratomileusis (LASIK).
Scope & Applicability
Product Classes
5The device is intended to shave tissue from sections of the cornea; device used for cutting the cornea
Guidance for premarket notification submissions for replacement blades
General manual surgical instruments exempt from 510(k)
specific type of keratome requiring successful flap percentage testing
Low risk medical devices
Stakeholders
2Entity responsible for submitting NDINs
Entity that established original safety and performance specifications
Regulatory Context
Attributes
5variability associated with cuts using same device and operator
Accuracy and repeatability info required in labeling
Accuracy and repeatability info required in labeling
Accuracy and repeatability info required in labeling
variability associated with cuts using different devices and operators
Identified Hazards
Hazards
3Risk mitigated by special controls
Potential risk for medical electrical equipment failing to operate properly.
Identified risk including keratitis and epithelial ingrowth
Related CFR Sections (5)
- 21CFR807.81§ 807.81 When a premarket notification submission is required.
(a) Except as provided in paragraph (b) of this section, each person who is required to register his establishment pursuant to § 807.20 must submit a premarket notification submission to the Food and Drug Administration at least 90 days before he proposes to begin the introduction or delivery for inRead full regulation →
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read full regulation →
- 21CFR886.4370§ 886.4370 Keratome.
(a) 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.Read full regulation →
- 21CFR878.4810§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a) Identification.Read full regulation →
- 21CFR801.109§ 801.109 Prescription devices.
A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which “adequate directions for use” canRead full regulation →
Related Warning Letters (10)
- 2025-12-09
CGMP/QSR/Medical Devices/Adulterated
Envoy Medical Inc.
- 2025-11-25
CGMP/QSR/Medical Devices/Adulterated
Hong Qiangxing Shenzhen Electronics Limited
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated
Contec Medical Systems Co., Ltd.
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Royal Philips
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Qianjiang Kingphar Medical Material Co Ltd.
- 2025-10-21
CGMP/QSR/Medical Devices/Adulterated
LEVO AG
- 2025-10-07
CGMP/QSR/Medical Devices/Adulterated
Technological Medical Advancements LLC
- 2025-09-23
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
The Richline Group, Inc.
- 2025-09-16
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
SeniorLife Technologies, Inc.
- 2025-08-26
CGMP/QSR/Medical Devices/Adulterated
Miach Orthopaedics
See Also (8)
- 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review: Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations (Status: Final)
- Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Display Devices for Diagnostic Radiology: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Intravascular Administration Sets Premarket Notification Submissions [510(k)]: Guidance for Industry and FDA Staff (Status: Final)
- Hemodialysis Blood Tubing Sets - Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff (Status: Final)
- Dental Handpieces - Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff (Status: Final)