PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES

Accessories, Solution, Ultrasonic Cleaners For Lenses

PURILENS, INC.

The following data is part of a premarket notification filed by Purilens, Inc. with the FDA for Purilens System For Cleaning And Disinfecting Contact Lenses.

Pre-market Notification Details

• Device ID: K991965
• 510k Number: K991965
• Device Name: PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES
• Classification: Accessories, Solution, Ultrasonic Cleaners For Lenses
• Applicant: PURILENS, INC. 12300 TWINBROOK PKWY. SUITE 625 Rockville, MD 20852
• Contact: Richard E Lippman
• Correspondent: Richard E Lippman; PURILENS, INC. 12300 TWINBROOK PKWY. SUITE 625 Rockville, MD 20852
• Product Code: LYL
• CFR Regulation Number: 886.5928 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-06-10
• Decision Date: 1999-10-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00830002000070	K991965	000
00830002000056	K991965	000
00830002000049	K991965	000
00830002000032	K991965	000