GEO MEDICAL CO., LTD. · Class II · Cleared Apr 29, 2026
| K-number | K253885 |
| Device name | PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON WATER BALANCE-1DAY COLOR (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENSES |
| Applicant | GEO MEDICAL CO., LTD. |
| Product code | LPL |
| Device class | Class II |
| Decision date | Apr 29, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 886.5925 |
The PUSCON WATER BALANCE-1DAY TINT and PUSCON WATER BALANCE-1DAY COLOR are daily disposable soft contact lenses made from omafilcon A material (59% water, 41% polymer) indicated for single-use correction of myopia in non-diseased eyes. The tint version uses a visibility dye (C.I. Reactive Blue 69), while the color version uses pad-printed FDA-listed color additives to enhance or alter eye appearance. Both incorporate UV absorbers and are discarded after each removal.
The devices use omafilcon A, an FDA Group 2 material (>50% water, non-ionic polymer) manufactured via cast molding with steam sterilization. Key parameters include 59% water content, oxygen permeability of 27 ± 20%, refractive index 1.400 ± 0.005, and UV blocking >95% in UVB and >50% in UVA ranges. Color lenses employ pad-printing technology to entrap colorants in the lens material without altering baseline lens characteristics.
Testing followed ISO 10993-5 (cytotoxicity), ISO 10993-11 (systemic toxicity), ISO 10993-23 (ocular irritation), ISO 10993-10 (sensitization), ISO 11737-2 (sterility), ASTM F1929-23 (package integrity), ASTM F88 (seal strength), ISO 18369-2 (tolerances), ISO 18369-3 (physical properties), and ISO 18369-4 (material properties). All toxicology testing was conducted under Good Laboratory Practice (GLP) regulations.
The subject device is substantially equivalent to three predicate devices—Aveo (K180985), Innova Vision Hydrogel (K222954), and Pegavision Color (K200296)—because it shares the same omafilcon A material, FDA Group 2 classification, daily disposable use, cast-molded production, steam sterilization, and comparable physical/material properties. For color variants, it employs the same pad-printing tinting method as Pegavision. Non-clinical testing demonstrates equivalent safety and effectiveness with no cytotoxicity, no ocular irritation, and stable specifications through shelf life.
View the full FDA submission: accessdata.fda.gov