510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853790Substantially Equivalent

Babe Shade-Infant Ambient Light Intensity Reducer

Rocky Mountain Medical Corp., Greenwood Village CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853790 is the FDA 510(k) clearance record for BABE SHADE-INFANT AMBIENT LIGHT INTENSITY REDUCER, a class I device, cleared for Rocky Mountain Medical Corp. on under FDA product code HQY (Sunglasses (Non-Prescription Including Photosensitive)). FDA records list 9 510(k) clearances for Rocky Mountain Medical Corp., from to . As of , FDA records show no recalls naming K853790.

Clearance record

Decision date
Received
(24 days to decision)
Product code
HQY Sunglasses (Non-Prescription Including Photosensitive)
Regulation
21 CFR 886.5850
Device class
Class I
Review panel
Ophthalmic
Applicant
Rocky Mountain Medical Corp. 5680 S. Syracuse Cir., Greenwood Village CO
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