Product code ILY: 510(k) clearances and predicates
Product code ILY covers CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.). FDA lists 229 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
229 clearances on file under product code ILY. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 so far | 1 |
Recent clearances
Newest ILY clearances in the FDA index, with applicant and decision date:
- K253965, CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.), applicant Wuhan PHOMED Technology Company , Ltd., decided 2026-03-19. FDA record
- K242755, Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B), applicant Gigaalaser Company , Ltd., decided 2025-05-19. FDA record
- K231997, SIRONA 100 Therapy Laser System (OEM's Model EVANLAS), applicant Cure Point Therapeutics, Inc., decided 2024-10-15. FDA record
- K223642, LED Lip Perfector, model: ZC-05, applicant Light Tree Ventures Europe B.V., decided 2023-03-09. FDA record
- K221189, OLIZ LTB-1000A, applicant Ltbio Co., Ltd., decided 2022-08-29. FDA record
- K213524, CytonPro-5000, applicant Cytonsys, Inc., decided 2022-08-10. FDA record
- K202028, dermalux Flex MD, applicant Aesthetic Technology, Ltd., decided 2020-12-16. FDA record
- K171087, AXON IR Heat Lamp, applicant Crystal Medtech, LLC, decided 2017-07-07. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B), SIRONA 100 Therapy Laser System (OEM's Model EVANLAS). Watch new ILY clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code ILY?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent ILY clearances include CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.).
How many 510(k) clearances use product code ILY?
229 at the time this page was generated, from openFDA records.
How do I find a predicate device under ILY?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new ILY clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.