Question 1

Who is the manufacturer of LABTICIAN RETINAL IMPLANTS?

Accepted Answer

Labtician Products, Inc. filed the 510(k) submission for LABTICIAN RETINAL IMPLANTS (K875014).

Question 2

What is the FDA product code for LABTICIAN RETINAL IMPLANTS?

Accepted Answer

HQJ. It is classified under 21 CFR 886.3300 as a Class 2 device in the Ophthalmic panel.

Question 3

When was LABTICIAN RETINAL IMPLANTS cleared by the FDA?

Accepted Answer

Feb 26, 1988 (decision: SESE).

Question 4

What is the regulatory pathway for LABTICIAN RETINAL IMPLANTS?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like LABTICIAN RETINAL IMPLANTS?

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	K875014
Device Name	LABTICIAN RETINAL IMPLANTS
Applicant	Labtician Products, Inc.
Product Code	HQJ · Ophthalmic
Decision Date	Feb 26, 1988
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 886.3300
Device Class	Class 2

LABTICIAN RETINAL IMPLANTS

Device Facts

Regulatory Classification

Identification