Focus Cap Array

FDA UDI

Class II (US FDA UDI)

by Cynosure, LLC

Identity

Trade Name: Focus Cap Array FDA UDI
Generic Name: Dermatological solid-state laser system FDA UDI
Device Name: PicoSure Focus Cap Array FDA UDI
Model / Reference: 100-7012-055 FDA UDI
Description: PicoSure Focus Cap Array FDA UDI

Identifiers

Primary DI / UDI-DI: 00841494100025 FDA UDI
510(k) Number: K121346 FDA UDI
K133364 FDA UDI
K140719 FDA UDI
K143105 FDA UDI
FDA Product Code: GEX FDA UDI
GMDN Term: Dermatological solid-state laser system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4810 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Dermatological solid-state laser system

Focus Cap Array by Cynosure, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dermatological solid-state laser system.

CLARITY II — Lutronic Corporation · Class II
AuraLux — Acclaro Corporation · Class II
GentleMax Pro — Candela Corporation · Class II
CLARITY II — Lutronic Corporation · Class II
GentleYAG — Candela Corporation · Class II
Splendor X — Bios, Inc. · Class II
EPY-50 — DDC TECHNOLOGIES, INC. · Class II
Canister HFC-134a /980g, ALUM, 15 pack — Candela Corporation · Class II

Cleared under the same submission

K121346 also covers:

Spacer tip, handpiece — Cynosure, LLC

K133364 also covers:

Spacer tip, handpiece — Cynosure, LLC

K140719 also covers:

Spacer tip, handpiece — Cynosure, LLC

K143105 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Cynosure, LLC

Sources (1)

FDA UDI 845ba25d-0b17-44b6-91b6-84a6d4e1f44d 34 fields · synced Jun 8, 2026