FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49%
K Number: K030027
·
Decision Apr 1, 2003
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
485
Applicant Total
4
Review Days
88
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Basic Information
- Device Name
- GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49%
- K Number
- K030027
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Gelflex Laboratories
- Date Received
- January 3, 2003
- Decision Date
- April 1, 2003
- Product Code
- LPL
- 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 |
|---|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | FDA class 2 | Ophthalmic |
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Other Clearances by Gelflex Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K181558 | Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens | Sep 6, 2018 | Substantially Equivalent |
| K962710 | GELFLEX DELTA 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS | Sep 5, 1996 | Substantially Equivalent |
| K962711 | GELFLEX ALPHA (POLYMACON) HYDROPHILIC CONTACT LENS | Sep 5, 1996 | Substantially Equivalent |