20G SMA LASER FIBER, MODEL LF100

Laser, Ophthalmic

OPHTHALMED LLC

The following data is part of a premarket notification filed by Ophthalmed Llc with the FDA for 20g Sma Laser Fiber, Model Lf100.

Pre-market Notification Details

• Device ID: K050807
• 510k Number: K050807
• Device Name: 20G SMA LASER FIBER, MODEL LF100
• Classification: Laser, Ophthalmic
• Applicant: OPHTHALMED LLC 1308 MORNINGSIDE PARK DR. Alpharetta, GA 30022
• Contact: Jay Mansour
• Correspondent: Jay Mansour; OPHTHALMED LLC 1308 MORNINGSIDE PARK DR. Alpharetta, GA 30022
• Product Code: HQF
• CFR Regulation Number: 886.4390 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-03-30
• Decision Date: 2005-09-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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