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HyPHo Laser System

by Hyper Photonics SRL

510(k) K163449

HyPHo Laser System is a Class II device made by Hyper Photonics SRL, cleared under FDA 510(k) K163449 on 23 Jun 2017, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK163449 Date23 Jun 2017ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
GEX
Device class
Class II
Regulation
21 CFR Part 878.4810
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K163449

11 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K163449
UDI-DISize and differences
HYPHO HH068000
HYPER PHOTONICS SRL
HH06800008051272100310
Single use: no
On the market
MultiPulse Ho J19-1310-000
Asclepion Laser Technologies GmbH
J19-1310-00004058784001092
Single use: no
On the market
O35 HH066000
HYPER PHOTONICS SRL
HH06600008051272100334
Single use: no
On the market
Re-Usable surgical optical fiber BO000012
HYPER PHOTONICS SRL
BO00001208051272101034
Single use: no
On the market
Re-Usable surgical optical fiber BO000014
HYPER PHOTONICS SRL
BO00001408051272101096
Single use: no
On the market
Re-Usable surgical optical fiber BO000016
HYPER PHOTONICS SRL
BO00001608051272101157
Single use: no
On the market
Re-Usable surgical optical fiber BO000018
HYPER PHOTONICS SRL
BO00001808051272101218
Single use: no
On the market
Single use surgical optical fiber BO000013
HYPER PHOTONICS SRL
BO00001308051272101065
Single use: yes
On the market
Single use surgical optical fiber BO000015
HYPER PHOTONICS SRL
BO00001508051272101126
Single use: yes
On the market
Single use surgical optical fiber BO000017
HYPER PHOTONICS SRL
BO00001708051272101188
Single use: yes
On the market
Single use surgical optical fiber BO000019
HYPER PHOTONICS SRL
BO00001908051272101249
Single use: yes
On the market

Similar devices

Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).

Other devices from Hyper Photonics SRL

See all devices from Hyper Photonics SRL →