JOULE CLEARSENSE LASER SYSTEM— 510(k) K111483

Substantially Equivalent

Sciton, Inc

FDA 510(k) clearance K111483 for JOULE CLEARSENSE LASER SYSTEM, Substantially Equivalent on 2011-12-07. Applicant: Sciton, Inc. Device class: 2.

Clearance details

Applicant: Sciton, Inc
Product code: Code PDZ
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2011-05-31
Decision date: 2011-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PDZ

K253960 — Medicell Mycosis Laser (MCML24004)2026-03-09
K241116 — Onycho Laser V2024-07-22
K211265 — TFX-LT2000 Therapy Light2022-11-17
K221363 — AF Laser2022-07-20
K190034 — REMY Medical Therapy Laser System2019-05-15

More clearances from Sciton, Inc

K251077 — JOULE 1064nm System and Accessories2025-12-19
K222958 — mJOULE RF System and Accessories2024-04-23
K213761 — Joule diVa System2022-07-19
K213350 — mJOULE System and Accessories2022-04-15
K182173 — Joule System2019-03-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.