510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K953627Substantially Equivalent

New Sun Optical Non Prescription Sunglasses

New Sun Optical Enterprise Co., Ltd., Taiwan Hsien, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953627 is the FDA 510(k) clearance record for NEW SUN OPTICAL NON PRESCRIPTION SUNGLASSES, a class I device, cleared for New Sun Optical Enterprise Co., Ltd. on under FDA product code HQY (Sunglasses (Non-Prescription Including Photosensitive)). FDA records list one 510(k) clearance for New Sun Optical Enterprise Co., Ltd. As of , FDA records show no recalls naming K953627.

Clearance record

Decision date
Received
(86 days to decision)
Product code
HQY Sunglasses (Non-Prescription Including Photosensitive)
Regulation
21 CFR 886.5850
Device class
Class I
Review panel
Ophthalmic
Applicant
New Sun Optical Enterprise Co., Ltd. # 105 Tzu Chang Rd., Taiwan Hsien, TW
510(k) summary
Statement
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