Cleared Traditional

K893630 - CANDELA UPC LASER PHOTOCOAGULATOR

K893630 is the FDA 510(k) clearance for CANDELA UPC LASER PHOTOCOAGULATOR by Candela Laser Corp.. It is a Class 2 Ophthalmic device (product code HQF) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K893630 · Candela Laser Corp. · Ophthalmic device
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Aug 1989
Decision
83d
Days
Class 2
Risk

K893630 is an FDA 510(k) clearance for the CANDELA UPC LASER PHOTOCOAGULATOR. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Candela Laser Corp. (Wayland, US). The FDA issued a Cleared decision on August 2, 1989 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4390 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Candela Laser Corp. devices

Submission Details

510(k) Number K893630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1989
Decision Date August 02, 1989
Days to Decision 83 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 110d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQF Laser, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4390
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HQF Laser, Ophthalmic

All 64
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K893630.
MICROLASE BY LASER TRABECULOPLASTY
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