510(k) K200747

Device

PuriLens Plus Preservative Free Saline

Applicant

The LifeStyle Company, Inc.

510(k) number

K200747

Product code

510(K) PREMARKET NOTIFICATION // QUICK LINKS: SKIP TO MAIN PAGE CONTENT SKIP TO SEARCH SKIP TO TOPICS MENU SKIP TO COMMON LINKS U.S. FOOD & DRUG ADMINISTRATION   FOLLOW FDA EN ESPAñOL SEARCH FDA   HOME FOOD DRUGS MEDICAL DEVICES RADIATION-EMITTING PRODUCTS VACCINES, BLOOD &

Decision

Substantially Equivalent (SESE)

Decision date

2020-05-15

Date received

2020-03-23

Regulation

510(k) Premarket Notification

Classification name

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la

Medical specialty

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

Review panel

Ophthalmic

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No