Question 1

Who is the manufacturer of LASER LENS-VARIOUS MODELS?

Accepted Answer

Meditec of America filed the 510(k) submission for LASER LENS-VARIOUS MODELS (K834610).

Question 2

What is the FDA product code for LASER LENS-VARIOUS MODELS?

Accepted Answer

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

Question 3

When was LASER LENS-VARIOUS MODELS cleared by the FDA?

Accepted Answer

Apr 5, 1984 (decision: SESE).

Question 4

What is the regulatory pathway for LASER LENS-VARIOUS MODELS?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like LASER LENS-VARIOUS MODELS?

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	K834610
Device Name	LASER LENS-VARIOUS MODELS
Applicant	Meditec of America
Product Code	HQF · Ophthalmic
Decision Date	Apr 5, 1984
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 886.4390
Device Class	Class 2

LASER LENS-VARIOUS MODELS

Device Facts

Regulatory Classification

Identification