510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K897090Substantially Equivalent

Sunglasses

Pt Midas Surya Optical Co., Jakarta 13930 Indonesia, ID / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K897090 is the FDA 510(k) clearance record for SUNGLASSES, a class I device, cleared for Pt Midas Surya Optical Co. on under FDA product code HQY (Sunglasses (Non-Prescription Including Photosensitive)). FDA records list 2 510(k) clearances for Pt Midas Surya Optical Co., from to . As of , FDA records show no recalls naming K897090.

Clearance record

Decision date
Received
(251 days to decision)
Product code
HQY Sunglasses (Non-Prescription Including Photosensitive)
Regulation
21 CFR 886.5850
Device class
Class I
Review panel
Ophthalmic
Applicant
Pt Midas Surya Optical Co. Jl. Rawa Sumur Barat # 1, Jakarta 13930 Indonesia, ID
Third party review
No

Clearances, product code HQY

Trailing 12 months

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

FDA records show no clearances under product code HQY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HQY, 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