GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49%
FDA 510(k) clearance K030027 · decided 2003-04-01
Clearance details
- K-number
- K030027
- Device name
- GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49%
- Applicant
- Gelflex Laboratories
- Decision
- Substantially Equivalent
- Date received
- 2003-01-03
- Decision date
- 2003-04-01
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Perth, Western, Wa, AU
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.