Recall Z-0348-2014— Candela Corporation
Class II · Terminated
Class II FDA medical device recall by Candela Corporation, initiated 2013-11-06, terminated 2015-06-08. It names 3 FDA 510(k) clearances: K024260, K024335, K972767. Product: Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 9914-00-9015. and Candela Laser GentleLase Pro LE, Model number: 9914-00-9040. Reason: Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause injury..
- Recalling firm
- Candela Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-11-06
- Terminated
- 2015-06-08
- Firm location
- Wayland, MA, United States
510(k) clearances named in this recall
3 on FDA's record- K024260 — CANDELA GENTLELASE FAMILY OF LASER SYSTEMS
- K024335 — CANDELA GENTLELASE FAMILY OF LASER SYSTEMS
- K972767 — CANDELA GENTLELASE GL DERMATOLOGICAL VASCULAR LESION LASER
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 9914-00-9015. and Candela Laser GentleLase Pro LE, Model number: 9914-00-9040
Reason for recall
Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause injury.
Data sourced from openFDA. This site is unofficial and independent of the FDA.