Question 1

Who is the manufacturer of MODEL 900S INTRAOCULAR PROBE?

Accepted Answer

Lumenis, Inc. filed the 510(k) submission for MODEL 900S INTRAOCULAR PROBE (K812219).

Question 2

What is the FDA product code for MODEL 900S INTRAOCULAR PROBE?

Accepted Answer

HQF. It is classified under 21 CFR 886.4390 as a Class 2 device in the Ophthalmic panel.

Question 3

When was MODEL 900S INTRAOCULAR PROBE cleared by the FDA?

Accepted Answer

Nov 16, 1981 (decision: SESE).

Question 4

What is the regulatory pathway for MODEL 900S INTRAOCULAR PROBE?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like MODEL 900S INTRAOCULAR PROBE?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K812219
Device Name	MODEL 900S INTRAOCULAR PROBE
Applicant	Lumenis, Inc.
Product Code	HQF · Ophthalmic
Decision Date	Nov 16, 1981
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 886.4390
Device Class	Class 2

MODEL 900S INTRAOCULAR PROBE

Device Facts

Regulatory Classification

Identification