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Candela Corporation

United States·US-MF-000022750

Last updated September 17, 2026

Information

Country: United States
Address: 251, Locke Drive, Marlborough, United States
Website: candelamedical.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +19253258206
PRRC Contact: Greg Wallender
EUDAMED SRN: US-MF-000022750
FDA FEI Number: 3016496662
DUNS Number: —

Catalogue (528)

Page 1 of 11

Device	Model / Reference	Registries	Class	Status
Focal 44 Sublative iD (200 Pulses)	AS79354	FDA UDI	Class II	Active
GentleMax Pro	9914-16-9035	FDA UDI	Class II	Active
Profound System, Packaged	FG70514	FDA UDI	Class II	Active
Alex TriVantage 755 Delivery System Upgrade	7122-00-9609	FDA UDI	Class II	Unknown
GMPP ACC Large Spot Option Kit, w/HP, w/SAs, w/Fiber Assembly	7123-CE-0653	FDA UDI	Class II	Unknown
Vbeam Aesthetica Distance Gauge Kit	7122-00-3754	FDA UDI	Class II	Active
Alex TriVantage 532 PT Handpiece Assembly	7122-00-9154	FDA UDI	Class II	Active
Vbeam Perfecta	9914-08-0300	FDA UDI	Class II	Active
GentleYAG LE	9914-09-1022	FDA UDI	Class II	Active
GentleYAG	9914-00-0962	FDA UDI	Class II	Unknown
Profound, SubQ Single- Use Cartridge, Packaged	AS87913	FDA UDI	Class II	Active
Profound Matrix	FG71841	FDA UDI	Class II	Unknown
GentleYAG	9914-09-1032	FDA UDI	Class II	Active
Vbeam Platinum	9914-08-0312	FDA UDI	Class II	Active
Assy, Delivery Sys, Dcd Hp, Prima Refurbished	7123-57-0433	FDA UDI	Class II	Active
GentleLase LE Delivery System W/O	0800-00-0970	FDA UDI	Class II	Active
GentleYAG 1.5/3MM Delivery System W/O DCD	7122-00-3558	FDA UDI	Class II	Active
PRO Series Fiber Assembly	7122-00-9419	FDA UDI	Class II	Active
GentleYAG SR Delivery System W/DCD	0800-00-1054	FDA UDI	Class II	Unknown
GentleLASE	9914-11-0930	FDA UDI	Class II	Unknown
Profound Matrix	FG71841	FDA UDI	Class II	Active
Nordlys System	9SYS7751-203	FDA UDI	Class II	Active
GentleMax	9914-00-0412	FDA UDI	Class II	Unknown
GentleLASE	9914-00-2130	FDA UDI	Class II	Unknown
GentleYAG	9914-08-1022	FDA UDI	Class II	Active
GentleLASE	9914-12-0890	FDA UDI	Class II	Unknown
GentleYAG	9914-08-0962	FDA UDI	Class II	Active
Diode Handpiece Assembly	7122-00-2050	FDA UDI	Class II	Unknown
GentleLASE	9914-12-0888	FDA UDI	Class II	Unknown
Assy, Dcd Hand Piece, Large Spot, Gmpp	7123-CE-0631	FDA UDI	Class II	Active
Acc Hand Piece, Large Spot, Gmpp	7123-CE-0628	FDA UDI	Class II	Unknown
Applicator Frax 1550 1550 nm	9APP7829-CNDL	EUDAMEDFDA UDI	Class II	Active
Fiber, Standard, Hc, Gmpp	7123-CE-0658	FDA UDI	Class II	Active
Vbeam Aesthetica	9914-00-0321	FDA UDI	Class II	Active
Sublime applicator	FG70551	FDA UDI	Class II	Active
Vbeam Aesthetica	9914-08-0321	FDA UDI	Class II	Active
GentleYAG LE Delivery System W/O DCD	0800-00-1065	FDA UDI	Class II	Unknown
Sublime Applicator, Profound Matrix	FG71871	FDA UDI	Class II	Active
Lens, Gold & Silver	AS92041	FDA UDI	Class II	Active
Alex TriVantage Delivery System	7122-00-0921	FDA UDI	Class II	Active
GentleYAG	9914-00-0950	FDA UDI	Class II	Unknown
Canister HFC-134a /980g, ALUM, 1 pack	1600-00-0229	FDA UDI	Class II	Active
Vbeam 7MM Delivery System W/O DCD	7122-00-3156	FDA UDI	Class II	Active
3MM Handpiece Assembly	7122-00-1100	FDA UDI	Class II	Unknown
Large Spot Specialty Delivery System Assembly	7122-00-9760	FDA UDI	Class II	Active
Large Spot Fiber Assembly	7122-00-9746	FDA UDI	Class II	Active
GentleMax	9914-00-0402	FDA UDI	Class II	Unknown
Matrix Pro Applicator, Profound Matrix	FG71851	FDA UDI	Class II	Unknown
MGL 6/8/10MM RGD Fiber	7122-00-3833	FDA UDI	Class II	Unknown
GentleYAG SR Delivery System W/DCD	0800-00-1055	FDA UDI	Class II	Unknown

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FDA Recalls (5)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 10, 2019	Z-0209-2020	—	terminated	The canister neck bushing may become loose and separate from the body of the canister during use. The issue occurs only when the canisters are used in Candela legacy devices that utilize screw-in or threaded interface type DCD modules
Sep 10, 2019	Z-0206-2020	—	terminated	The canister neck bushing may become loose and separate from the body of the canister during use. The issue occurs only when the canisters are used in Candela legacy devices that utilize screw-in or threaded interface type DCD modules
Sep 10, 2019	Z-0207-2020	—	terminated	The canister neck bushing may become loose and separate from the body of the canister during use. The issue occurs only when the canisters are used in Candela legacy devices that utilize screw-in or threaded interface type DCD modules
Sep 10, 2019	Z-0208-2020	—	terminated	The canister neck bushing may become loose and separate from the body of the canister during use. The issue occurs only when the canisters are used in Candela legacy devices that utilize screw-in or threaded interface type DCD modules
Nov 6, 2013	Z-0348-2014	—	terminated	Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause injury.