510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K231997Substantially Equivalent

SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)

Cure Point Therapeutics, Inc, Cheyenne WY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K231997 is the FDA 510(k) clearance record for SIRONA 100 Therapy Laser System (OEM's Model EVANLAS), a class II device, cleared for Cure Point Therapeutics, Inc. on under FDA product code ILY (Lamp, Infrared, Therapeutic Heating). FDA records list one 510(k) clearance for Cure Point Therapeutics, Inc. As of , FDA records show no recalls naming K231997.

Clearance record

Decision date
Received
(468 days to decision)
Product code
ILY Lamp, Infrared, Therapeutic Heating
Regulation
21 CFR 890.5500
Device class
Class II
Review panel
Physical Medicine
Applicant
Cure Point Therapeutics, Inc. 1712 Pioneer Ave., Suite 2606, Cheyenne WY
510(k) summary
Statement
Third party review
No

Clearances, product code ILY

Trailing 12 months
1 clearance under product code ILY in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code ILY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260