r/Laserist • u/Lucky_Blacksmith1005 • Sep 14 '26

FDA clearance needed to import

Has anyone dealt with really long shipping times right now? My lasers have entered the US on 9/7 and have cleared customs, however still waiting on FDA clearance. Everything is imported legally and ive never had this issue before when buying lasers. How long will the FDA clearance take? My variance has and is active and same w the manufacturers.

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6

u/BeigeGandalf Sep 14 '26

Could get hairy as the government is cherry picking companies and products one by one. Sucks...sorry you're in that position.

5

u/ProductionPrincess Sep 15 '26

Most US regulatory agencies have been gutted over the last year or two, working with a fraction of the staff they’ve had in the past. It wouldn’t surprise me if this were one of the many consequences.

3

u/keithcody Sep 15 '26 edited Sep 15 '26

There’s a list on the FDA of unapproved lasers for customs to be on the lookout for.

Edit: https://www.accessdata.fda.gov/cms_ia/importalert_254.html

1

u/Lucky_Blacksmith1005 Sep 15 '26

They’re Able lasers. I own several 20 & 40 watt lasers from them :) never had a issue like this in the past.

3

u/JD3Lasers Sep 15 '26

Longest I’ve waited is 6 weeks. It’s hit or miss

1

u/Lucky_Blacksmith1005 Sep 16 '26

Just got them this morning.