FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISPOSABLE N-PE MICKROKERATOME BLADES
K Number: K032297
·
Decision Aug 26, 2003
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
82
Applicant Total
17
Review Days
32
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- DISPOSABLE N-PE MICKROKERATOME BLADES
- K Number
- K032297
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 886.4370
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Oasis Medical, Inc.
- Date Received
- July 25, 2003
- Decision Date
- August 26, 2003
- Product Code
- HNO
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HNO | Keratome, Ac-Powered | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HNO), ordered by most recent decision date.
VisuMax Femtosecond Laser
FDA 510(k)
FDA Class 1
·Ophthalmic
EPI K Console
FDA 510(k)
FDA Class 1
·Ophthalmic
EPIVISION SL SYSTEM
FDA 510(k)
FDA Class 1
·Ophthalmic
CARRIAZO-PENDULAR MICROKERATOME
FDA 510(k)
FDA Class 1
·Ophthalmic
ZYOPTIX XP EPI SEPARATOR SYSTEM
FDA 510(k)
FDA Class 1
·Ophthalmic
HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM
FDA 510(k)
FDA Class 1
·Ophthalmic
Other Clearances by Oasis Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K213988 | SOFT PLUG Extended Duration 180 Tapered Canalicular Plug | Jun 3, 2022 | Substantially Equivalent |
| K162361 | Soft Plug Extended Duration 180 Canalicular Plug | Apr 17, 2017 | Substantially Equivalent |
| K030401 | DISPOSABLE M2-PE MICROKERATOME BLADES | Jun 19, 2003 | Substantially Equivalent |
| K022205 | DISPOSABLE N-PE MICROKERATOME BLADES | Oct 3, 2002 | Substantially Equivalent |
| K013613 | SOFT PLUG ABSORBABLE PLUG-SA | Jun 27, 2002 | Substantially Equivalent |
| K003820 | DISPOSABLE CB-PE MICROKERATOME BLADES | Mar 8, 2001 | Substantially Equivalent |
| K001176 | DISPOSABLE MICROKERATOME BLADES-PE | Sep 21, 2000 | Substantially Equivalent |
| K980437 | SILICONE PUNCTAL PLUG | Apr 30, 1998 | Substantially Equivalent |
| K950798 | POSTERIOR CAPSULE SHIELD | May 22, 1995 | Substantially Equivalent |
| K950241 | OPHTHALMIC SPONGES | Feb 27, 1995 | Substantially Equivalent |