510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K183200Substantially Equivalent

iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses

C&E GP Specialist, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K183200 is the FDA 510(k) clearance record for iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses, a class II device, cleared for C&E GP Specialist, Inc. on under FDA product code MUW (Lens, Contact (Orthokeratology)). FDA records list one 510(k) clearance for C&E GP Specialist, Inc. As of , FDA records show no recalls naming K183200.

Clearance record

Decision date
Received
(51 days to decision)
Product code
MUW Lens, Contact (Orthokeratology)
Regulation
21 CFR 886.5916
Device class
Class II
Review panel
Ophthalmic
Applicant
C&E GP Specialist, Inc. 15970 Bernardo Center Dr., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MUW

Trailing 12 months

FDA records hold no clearances under product code MUW in the trailing twelve months.

FDA records show no clearances under product code MUW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MUW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260